Encelto
Product Images NDC 82958-501

Product Visual Gallery

This gallery contains 69 technical images submitted to the FDA as part of the official labeling for Encelto (NDC 82958-501). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Neurotech Pharmaceuticals, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Image Description (Encelto Corepack Label)

ENCELTO implant for intravitreal use by Neurotech Pharmaceuticals, Inc. The label indicates it is a single-dose implant containing allogeneic retinal pigment epithelial cells expressing recombinant human ciliary neurotrophic factor (hCNTF). It includes storage and administration instructions, a barcode, product NDC 82958-501-01, and a use-by date of 2025-03-11. The label warns not to open until day of use and states the product must not be used after the use-by date.*

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Figures 1 And 2 (Encelto Figure 1)

An instructional illustration showing two steps of a surgical procedure involving the eye. Figure 1 depicts the initial step with surgical instruments in contact with the eye's surface near the cornea. Figure 2 shows a subsequent step where a rectangular piece is being manipulated or removed from the eye area.*

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Image Description (Encelto Figure 16)

An illustration showing the components included in the ENCELTO Corepack by Neurotech Pharmaceuticals, Inc. The diagram labels seven parts: the Corepack container, an outer container holding the sterile inner container, a disposable temperature recording device, the ENCELTO Medium pH Color Guide, ENCELTO Instructions for Use, an ENCELTO Inspection Checklist, and United States Prescribing Information.*

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Image Description (Encelto Figure 17)

An illustration showing a cylindrical device labeled ENCELTO by Neurotech Pharmaceuticals, Inc. The device measures 6.5 mm in length and 1.3 mm in diameter, with a note indicating the image is not to scale. The device has a looped wire or filament protruding from one end.*

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Image Description (Encelto Figure 18)

An instructional diagram showing components of the ENCELTO drug product. Labeled parts include the lid film, luer lock cap, gripper, fixation loop, ENCELTO itself, and the liquid medium in a transparent container.*

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Image Description (Encelto Figure 19)

This image shows the ENCELTO Medium pH Color Guide from Neurotech Pharmaceuticals, Inc. It includes a pH color scale with four color blocks ranging from yellow to dark magenta, indicating acceptable pH ranges for the product's liquid medium. Instructions advise inspecting the product's pH prior to use and provide contact information if the pH is outside the acceptable range.*

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Figures 3 And 4 (Encelto Figure 2)

This illustration shows two figures demonstrating steps of a process. Figure 3 depicts a hand peeling back a protective seal from a small container with an orange cap inside. Figure 4 shows a pair of tweezers holding a small cylindrical object attached to a blue thread, with a dark, flat object nearby.*

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Figures 5 And 6 (Encelto Figure 3)

Two instructional medical illustrations related to eye surgery. Figure 5 shows an instrument held at a 90-degree angle to the surface of the eye, likely indicating the approach angle for insertion or treatment. Figure 6 depicts a forceps holding tissue with a needle or instrument inserted nearby, demonstrating a surgical technique involving precise manipulation around the eye.*

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Figures 7-9 (Encelto Figure 4)

Instructional illustrations related to the ENCELTO product, showing a sequence of handling or procedural steps involving a needle, suture, and tissue. Figures 7, 8, and 9 depict threading, insertion, and positioning techniques with surgical tools and material.*

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Figure 10 (Encelto Figure 5)

An instructional diagram labeled 'Figure 10' showing a curved needle and thread passing through a curved surface, illustrating a surgical or stitching technique with directional arrows indicating needle movement.*

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Figure 11 (Encelto Figure 6)

An instructional illustration showing a medical procedure involving the eye. The image depicts a close-up of an eye with surgical tools, including a forceps holding a small mesh or implant being positioned on the white part of the eye (sclera), suggesting an ophthalmic surgical technique.*

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Figure 12 (Encelto Figure 7)

An anatomical illustration showing a human eye secured with a speculum. The eye has surgical sutures indicated within a marked area on the sclera near the iris. The image likely depicts a surgical procedure involving the placement of sutures on the eye.*

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Figures 13 And 14 (Encelto Figure 8)

Two medical illustrations labeled Figure 13 and Figure 14 show surgical procedures. Figure 13 depicts the use of surgical scissors cutting a suture or stitch above a blue curved line. Figure 14 shows an anatomical view of an eye with surgical instruments manipulating tissue near the iris and cornea.*

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Figure 15 (Encelto Figure 9)

Illustration showing a surgical or procedural step involving two pairs of scissors manipulating a blue suture within a pinkish tubular structure. The image likely depicts a step in a medical procedure related to ENCELTO, emphasizing suture handling and cutting.*

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Image Description (Encelto Ifu 1)

FDA Label Image

Image Description (Encelto Ifu 10)

An illustrated overview of ENCELTO from Neurotech Pharmaceuticals, showing a detailed diagram of the ENCELTO capsule and its assembly within a sterile inner container filled with liquid medium. The image highlights components including the lid film, luer lock cap, gripper, fixation loop, ENCELTO capsule, and liquid medium, with a labeled diagram explaining each part's function in maintaining sterility and facilitating implantation.*

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Image Description (Encelto Ifu 11)

A product information text panel titled 'Storage and Handling' for ENCELTO by Neurotech Pharmaceuticals, Inc. It includes instructions for storage temperature, inspection of the temperature recording device, handling practices, and cautions regarding expiration and temperature exposure. The panel also contains a section on the ENCELTO Medium pH Color Guide, describing the acceptable pH range and appearance of the liquid medium, along with warnings about particle presence and pH suitability before use.*

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Image Description (Encelto Ifu 12)

Text panel titled 'Warnings' for ENCELTO from Neurotech Pharmaceuticals, Inc., outlining preparatory procedures, surgical site preparation, and ENCELTO preparation instructions. It emphasizes sterility and proper handling precautions, and provides a contact number for Neurotech in case of issues or concerns related to the product's condition or usage.*

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Image Description (Encelto Ifu 13)

A text page from the ENCELTO product labeling by Neurotech Pharmaceuticals, Inc., covering insertion and closure instructions for suturing ENCELTO, highlighting knot placement, suture handling, and precautions to avoid complications. The page also notes there are no specifications for the end of surgery.*

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Image Description (Encelto Ifu 14)

This text panel from Neurotech Pharmaceuticals includes warnings and instructions related to the ENCELTO removal procedure. It covers postoperative wound care risks and detailed steps for surgical site preparation, removal, closure, and the importance of careful handling of the polypropylene anchor suture to avoid complications.*

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Image Description (Encelto Ifu 15)

Drug information text panel for ENCELTO includes sections on Precautions, Contraindications, and Use with Standard Procedures. It discusses the lack of data on use in pregnant women, breastfeeding, and pediatric patients; contraindications for ocular infections and hypersensitivity to Endothelial Serum Free Media; and lists compatible ophthalmic diagnostic procedures such as ophthalmic ultrasound, indirect ophthalmoscopy, OCT, tonometry, and others.*

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Image Description (Encelto Ifu 16)

MRI Safety Information table for ENCELTO from Neurotech Pharmaceuticals, Inc. The table lists MRI parameters including static magnetic field strength (1.5T or 3.0T), orientation (horizontal, cylindrical bore), maximum spatial field gradient, RF polarization (circularly polarized), types of RF transmit and receive coils, operating mode, scan duration instructions, and notes on MR image artifact management.*

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Image Description (Encelto Ifu 17)

This page titled 'Insertion Procedure' from documentation for ENCELTO (revakinagene taroretcel-lwey) implant shows introductory text for the insertion procedure of the implant designed for intravitreal use. The page includes a stylized logo and blue abstract graphics in the corners.*

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Image Description (Encelto Ifu 18)

A procedural text panel from Neurotech Pharmaceuticals describing preoperative preparation for surgery involving the eye. It details surgical instruments such as microvitreoretinal and asymmetric blades, various sutures, and cautery tips. The panel also advises on patient preparation steps, anesthesia techniques, and includes a small illustration showing eye insertion preparation.*

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Image Description (Encelto Ifu 19)

Instructional text panel titled 'Preparatory Procedures' for ENCELTO insertion. It describes step-by-step procedures for inspecting the ENCELTO product and packaging on the day of surgery, including warnings and cautions about leakage, use-by date verification on the corepack, and checking the disposable temperature recording device for safe temperature exposure.*

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Image Description (Encelto Ifu 2)

The image shows the back panel of the ENCELTO medication packaging by Neurotech Pharmaceuticals, Inc. It features the company address in Cumberland, Rhode Island, U.S. License Number 2321, and states the product was approved by the U.S. Food and Drug Administration in March 2025. The panel background is solid dark blue with white text.*

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Image Description (Encelto Ifu 20)

Text instructions for inspecting ENCELTO prior to use, including verifying seals, liquid medium positioning, and suspension of ENCELTO in the liquid medium. Includes warnings not to use if containers are damaged or medium is compromised, and instructions to check the medium's pH using a color guide. Two diagrams illustrate ENCELTO's suspension in the liquid medium and the pH color guide inspection process.*

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Image Description (Encelto Ifu 21)

Instructional diagram titled 'ENCELTO Insertion Procedure' detailing the transfer of the inner container to a sterile field. It includes three steps: peeling back the lid film of the non-sterile outer container, removing the inner container with sterile technique, and performing a second inspection of ENCELTO. The page shows labeled figures illustrating opening the outer container, transferring the inner container, and inspecting ENCELTO with a pH color guide.*

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Image Description (Encelto Ifu 22)

Illustrations from the ENCELTO surgical preparation instructions by Neurotech Pharmaceuticals, Inc., showing steps for conjunctival peritomy and scleral dissection. The images depict creating an insertion site with surgical tools and dissecting the conjunctiva and Tenon's capsule from the sclera. Includes annotated warnings and notes on avoiding buttonholes and blood entry during the procedure.*

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Image Description (Encelto Ifu 23)

An instructional diagram from the ENCELTO insertion procedure by Neurotech Pharmaceuticals, Inc. It shows placement of a corneal-limbal traction suture in the inferior quadrant of the eye, accompanied by text advising use of a 7-0 Vicryl suture under microscopic visualization and caution to avoid anterior chamber penetration to prevent complications and visual impairment.*

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Image Description (Encelto Ifu 24)

An instructional diagram from Neurotech describing the procedure to perform a 3.0 mm sclerotomy, including illustrations showing measuring and marking the scleral incision, entering the sclera posterior to the limbus with a blade, and enlarging the incision to full thickness. Warnings and step-by-step guidance on incision length and placement are included.*

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Image Description (Encelto Ifu 25)

Page from the ENCELTO insertion procedure guide by Neurotech Pharmaceuticals, Inc. It includes two instructional illustrations: one showing how to confirm a full-thickness sclerotomy incision without spanning uveal tissue, and another depicting excision of prolapsed vitreous using a vitrectomy cutter prior to insertion. The text provides step-by-step procedural notes related to these images.*

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Image Description (Encelto Ifu 26)

Instructional page titled 'ENCELTO Preparation' from Neurotech Pharmaceuticals, Inc., showing step-by-step diagrams to prepare ENCELTO for insertion. The page includes text warnings and notes about handling, with two color illustrations depicting opening the inner container and unlocking/removing the luer lock cap from the inner container.*

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Image Description (Encelto Ifu 27)

This instructional panel titled 'ENCELTO Insertion Procedure' details step iii, which explains rinsing ENCELTO with at least 5 mL of sterile Balanced Salt Solution (BSS) prior to insertion and maintaining moisture by applying BSS every 10 minutes. It includes cautions about avoiding excipient exposure, surface contact, prolonged air exposure, and specifies using only BSS or similar solutions. A small illustration shows a pipette dispensing BSS into a container, labeled as Figure 23.*

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Image Description (Encelto Ifu 28)

Instructional diagram showing preparation of ENCELTO for insertion, including passing a 9-0 polypropylene suture needle through the fixation loop. The page includes detailed steps and a caution note regarding the use of alternative sutures, accompanied by a labeled figure of the suture needle passing through the fixation loop.*

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Image Description (Encelto Ifu 29)

Instructional illustrations showing the ENCELTO insertion and closure procedure. The diagrams depict insertion of ENCELTO at a 90-degree angle through the scleral incision, with guidance to avoid the lens and aim towards the optic nerve. Text includes warnings, cautions, and notes about the procedure and device handling.*

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Image Description (Encelto Ifu 3)

This image shows a patient card for ENCELTO from Neurotech Pharmaceuticals, Inc. It includes fields for patient information such as patient name, physician name, clinic name, clinic phone number, date of insertion, and LOT number, along with instructions advising patients to keep the card for future reference and share it with their eye care providers.*

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Image Description (Encelto Ifu 30)

An instructional diagram detailing a step for ENCELTO insertion by Neurotech Pharmaceuticals, Inc. The image shows forceps or needle holders squeezing a gripper in a specified area to release ENCELTO. Accompanying notes caution against squeezing below the indicated region to avoid damaging the gripper, which would make release difficult or impossible and require contacting Neurotech for replacement.*

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Image Description (Encelto Ifu 31)

Step-by-step instructional illustrations from the ENCELTO insertion procedure, showing how to create an anchor knot using a 3-1-1 suture technique and place the anchor knot at the apex of the fixation loop. The images include warnings and handling notes related to polypropylene suture management and knot placement.*

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Image Description (Encelto Ifu 32)

Instructional surgical illustrations demonstrating how to anchor ENCELTO to the sclera with polypropylene sutures. The diagrams show sutures passing at 90-99% scleral depth and verifying the anchor knot position at the fixation loop apex, accompanied by procedural warnings about suture placement and depth to avoid complications.*

FDA Label Image

Image Description (Encelto Ifu 33)

The image is a procedural instruction page titled 'ENCELTO Insertion Procedure' describing how to tie a polypropylene suture down to the sclera with a 3-1-1 knot. It includes notes on careful handling of the suture, a caution about alternative knots, and warnings regarding tension on the suture and needle management. The page contains a small illustration of the knot labeled 'Figure 32 Tie with a 3-1-1 knot.'*

FDA Label Image

Image Description (Encelto Ifu 34)

An instructional diagram from Neurotech Pharmaceuticals for the product ENCELTO, illustrating anchoring the device to the sclera by taking 2.0 mm long bites of the sclera with polypropylene suture. The diagram highlights correct suture placement beyond the sclerectomy, accompanied by warnings about avoiding passing the suture anterior or posterior to the incision and the risks of not burying suture ends.*

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Image Description (Encelto Ifu 35)

This image shows a section titled '4.3 Wound closure' from the ENCELTO insertion procedure guide by Neurotech Pharmaceuticals, Inc. It outlines the steps for scleral wound closure using 9-0 nylon sutures, including suturing techniques and knot rotation. The page includes three illustrations demonstrating nylon suture placement, locking throws, and knot rotation to ensure proper wound closure.*

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Image Description (Encelto Ifu 36)

Illustrations from the ENCELTO product instructions showing surgical steps for wound closure. One diagram depicts cutting the polypropylene suture flush to the sclera, and another shows performing conjunctival and Tenon's capsule closure using sutures and 3-point fixation with scleral bites.*

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Image Description (Encelto Ifu 37)

This text panel outlines part of the ENCELTO insertion procedure, including administering a sub-conjunctival steroid injection, performing indirect ophthalmoscopy to confirm placement, applying topical antibiotic to the eye surface, and optional patching to prevent conjunctival wound dehiscence. It includes warnings about potential complications and cautions against injecting antibiotics into the eye.*

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Image Description (Encelto Ifu 38)

This image shows a text panel from Neurotech Pharmaceuticals, Inc. labeled with their logo. It provides instructions for the end of surgery procedures and postoperative wound care for the product ENCELTO. The text includes guidance on completing a patient card, disposal of materials, antibiotic and steroid application instructions, and mentions complications referencing an adverse reactions section.*

FDA Label Image

Image Description (Encelto Ifu 39)

This image shows a section titled 'Removal Procedure' from the prescribing information or instructions for ENCELTO, an implant for intravitreal use containing revakinagene tarorectel-lwey. The page includes the ENCELTO logo and the phrase indicating it is related to the removal procedure of the implant.*

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Image Description (Encelto Ifu 4)

This image shows MRI safety information for ENCELTO, indicating that patients with this implant can be safely scanned under very specific MRI conditions. It references where to find full MRI safety details in the ENCELTO Instructions for Use and includes contact information for Neurotech Pharmaceuticals, Inc.*

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Image Description (Encelto Ifu 40)

Preoperative Procedure instructions from the ENCELTO product documentation by Neurotech Pharmaceuticals, Inc., detailing preparation for surgery including surgical instruments needed, suggested sutures, and patient preparation steps with local anesthesia techniques. Includes a small illustrative figure of preparing a patient's eye for a removal procedure.*

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Image Description (Encelto Ifu 41)

Illustration showing the surgical site preparation procedure for ENCELTO removal, including steps for conjunctival peritomy with corneal-limbal traction suture placement, creation of limbal peritomy and radial incision, dissection to expose sclera and insertion site, and use of wet-field cautery for hemostasis. Each step is accompanied by detailed eye diagrams.*

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Image Description (Encelto Ifu 42)

Instructional diagrams showing a 3-port small gauge vitrectomy procedure associated with ENCELTO. The images illustrate placing an infusion cannula in an eye, confirming the infusion line position within the vitreous cavity, and performing vitrectomy to remove vitreous around ENCELTO without disrupting its white portion. Accompanying text provides step-by-step surgical guidance.*

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Image Description (Encelto Ifu 43)

This page from the ENCELTO removal procedure guide details step 2.1 on locating and opening the incision. It includes notes on incision placement, cautery use, and cautions against cutting the polypropylene anchor suture. Two illustrations show the removal of nylon sutures and dissection of an incision around the anchor suture base.*

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Image Description (Encelto Ifu 44)

Instructional diagrams from Neurotech Pharmaceuticals' ENCELTO device manual showing surgical steps to handle a polypropylene anchor suture. The first diagram depicts cutting the polypropylene suture, and the second illustrates identifying the fixation loop within an opened incision site.*

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Image Description (Encelto Ifu 45)

This is a procedural instructional panel titled 'ENCELTO Removal Procedure' detailing the steps for removing the ENCELTO implant using toothed forceps. It includes warnings, notes about the white portion of the implant, and cautions to avoid damage or vitreous release. Accompanying illustrations show grasping the fixation loop and cutting off the remaining knot to fully remove the implant.*

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Image Description (Encelto Ifu 46)

An instructional diagram from Neurotech Pharmaceuticals illustrating the steps for removal wound closure during eye surgery. It shows vitreoretinal surgical steps including removal of prolapsed vitreous, closure of the sclerotomy with interrupted sutures, closure of the conjunctiva with sutures, and administration of subconjunctival antibiotic injection.*

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Image Description (Encelto Ifu 47)

A text panel titled 'Postoperative Wound Care' from the ENCELTO Removal Procedure instructions. It details section 3.1 on antibiotic and steroid application, including a warning about risks from failure to follow application. Instructions specify using a topical antibiotic solution 1 drop four times daily for 7 days and a steroid drop taper schedule starting day after surgery with prednisolone acetate 1% or equivalent, gradually reducing dosage over three weeks.*

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Image Description (Encelto Ifu 48)

A data table titled Explanation of Symbols listing common pharmaceutical packaging symbols and their descriptions, including prescription only, sterile device, manufacturer, date of manufacture, light protection, use by date, package damage warning, lot number, GTIN, serial number, and MR conditional. The page includes the Neurotech logo and is part of a document.*

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Image Description (Encelto Ifu 49)

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Image Description (Encelto Ifu 5)

Contents page from the ENCELTO patient and procedure manual by Neurotech Pharmaceuticals, Inc., listing sections including introduction, intended use, components, warnings, precautions, MRI information, detailed ENCELTO insertion and removal procedures, and an explanation of symbols. Page numbers for each section are provided.*

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Image Description (Encelto Ifu 50)

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Image Description (Encelto Ifu 51)

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Image Description (Encelto Ifu 52)

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Image Description (Encelto Ifu 6)

This image shows a text panel providing an introduction and description for ENCELTO by Neurotech Pharmaceuticals, Inc. It includes the intended use for treating idiopathic macular telangiectasia type 2 (MacTel), recommended dose instructions for single surgical intravitreal implantation, and a detailed product description highlighting ENCELTO as a single-dose, sterile, allogeneic gene therapy implant containing retinal pigment epithelial cells expressing rhCNTF.*

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Image Description (Encelto Ifu 7)

Text panel titled 'Components' describing the contents and handling instructions of the ENCELTO corepack for surgery use. It details the removal and inspection of the ENCELTO container, sterile packaging, and associated materials such as the Instructions for Use, pH Color Guide, Inspection Checklist, temperature recording device, and prescribing information.*

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Image Description (Encelto Ifu 8)

An illustrated diagram titled 'Components in the Corepack' for ENCELTO by Neurotech Pharmaceuticals, Inc. It shows seven numbered components: 1) Corepack box, 2) Outer container holding a sterile inner container, 3) Disposable temperature recording device, 4) ENCELTO Medium pH Color Guide, 5) ENCELTO Instructions for Use booklet, 6) ENCELTO Inspection Checklist, and 7) United States Prescribing Information document.*

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Image Description (Encelto Ifu 9)

A data table titled 'Description of Corepack components' detailing the components of the ENCELTO system by Neurotech Pharmaceuticals, Inc. It describes the inner container, outer container, disposable temperature recording device, pH color guide, instructions for use, inspection checklist, and USP prescribing information.*

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Image Description (Encelto Product Label)

Label for ENCELTO implant by Neurotech Pharmaceuticals, Inc., NDC 82958-501-01. It is a single-dose implant for intravitreal use containing allogeneic retinal pigment epithelial cells expressing recombinant human ciliary neurotrophic factor (rhCNTF). The label indicates no preservatives, sterile handling required, and contains a barcode and lot information. Manufacturer address and logo are included.*

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Image Description (Mr Conditional 2)

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Mr Conditional Info (Mr Conditional)

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.