Pinpoint Lymphatics Kit
Product Images NDC 66259-037

The SPY Elite Pack is a kit used in conjunction with the SPY Elite System for visualizing vessels, blood flow, and tissue perfusion. The kit includes six SPY Elite Drapes, six SPY Elite Kit IFUs, six 10 ml vials of Sterile Water for Injection, and six 25 mg vials of SPY AGENT™ GREEN (indocyanine green for injection, USP) that need to be reconstituted with sterile water diluent before use. The kit has an NDC number, Catalogue Number, and Batch Code with a use-by-date. The packaging and tray are not sterile, but the contents of the individual components are. The kit should not be reused, and if the immediate packaging is damaged, it should not be used. The manufacturer is Novadaq Technologies ULC, and the distributor is Carestream Health, Inc.*

This text describes a medical product called "SPY Elite Pack" which includes a substance called "SPY AGENT™ GREEN" used to visualize vessels, blood flow, and tissue perfusion. The pack contains vials of the substance which must be reconstituted with sterile water diluent before use and must be used within 6 hours. The text also includes information on the manufacturer and distributor of the product, as well as batch codes and use-by dates.*

The SPY Elite Kit is a medical product used with the SPY Elite System for visualizing vessels, blood flow, and tissue perfusion in the body. It includes a 25 mg vial of SPY AGENT™ GREEN (indocyanine green for injection, USP) and a sterile water diluent that must be mixed before use. The kit also includes a sterile drape and instructions for use. The product must be used within six hours of dilution and should be stored at controlled room temperature. The individual components are sterile, but the packaging and tray are not. The manufacturer is Novadaq Technologies ULC.*

The SPY Lymphatics Pack is a medical kit containing six kits with all the materials for performing six lymphatic mapping procedures. It contains 6x25mg vials of SPY AGENT™ GREEN, sterile water for injection, syringes, 22-gauge needles, and labels for syringes. The kit is for use with the Advanced Imaging Modality L10 and L11 Light Sources and 1688 Camera System and the PINPOINT System. The product comes with instructions for use and should not be reused. The manufacturer is Novadaq Technologies ULC, and it is assembled and distributed by Carestream Health, Inc. The kit's batch code and use-by date are provided, and it should be stored at a temperature of 20°C to 25°C.*

The SPY Lymphatics Pack is a kit for lymphatic mapping to be used with certain imaging systems, containing a vial of SPY AGENT™ GREEN with 25 mg of indocyanine green for injection, and sterile water diluent to be used before use. The kit must be used within 6 hours of reconstitution. The manufacturer is Novadaq Technologies ULC and it is assembled and distributed by Carestream Health, Inc. This text does not provide detailed information about the product's features, benefits or how it works.*

The SPY Lymphatics Kit is a medical kit used for lymphatic mapping with the AVM L10 and L11 Light Sources and 1688 Camera System and the PINPOINT System. The kit contains one 25 mg vial of VSWPY AGENT™ GREEN (indocyanine green for injection, USP) and two 10 ml vials of sterile water for injection, USP, among other components. It is important to note that the outside packaging and tray are not sterile and not to be reused. The kit must be used within 6 hours after reconstitution and stored at a temperature between 20°C and 25°C.*

The SPY Minimally Invasive Surgery (SPY-MIS) Pack contains SPY AGENT™ GREEN (indocyanine green for injection, USP) in vials of 25mg each, which are to be reconstituted with the accompanying sterile water diluent before use within 6 hours. These kits are for use with the Advanced Imaging Modality (AIM) and PINPOINT Systems and are intended for the visualization of vessels, blood flow, tissue perfusion, and extrahepatic biliary ducts. The pack includes six (6) SPY-MIS Kits with the components ideal for six SPY-MIS procedures, packaged as 6 SPY MIS Kits with syringes, needles, labels and syringe package inserts. The outside packaging and tray are not sterile, though the contents of the individual components are, and they come with use-by dates and batch codes. The product is manufactured by Novadaq Technologies ULC and is supported by customer service at 1-800-624-4422 toll-free. The product should be stored at 20°C to 25°C (68°F to 77°F) where the temperature is controlled.*

The SPY Minimally Invasive Surgery (SPY-MIS) Pack is a kit used for visualization of vessels, blood flow, tissue perfusion, and extrahepatic biliary ducts. It contains the SPY AGENT™ GREEN (indocyanine green for injection, USP), 25 mg per vial. The pack should be reconstituted with accompanying sterile water diluent before use and used within 6 hours of reconstitution. The kit is designed for use with the Advanced Imaging Modality (AIM) and PINPOINT Systems. It is manufactured by Novadaq Technologies ULC and distributed by Carestream Health, Inc. The product should be stored at 20°C to 25°C (68°F to 77°F) according to the provided USP Controlled Room Temperature specifications.*

The SPY Minimally Invasive Surgery (SPY-MIS) Kit contains SPY AGENT™ GREEN for injection, USP. The kit is designed for use with the Advanced Imaging Modality (AIM) and PINPOINT Systems. This kit allows visualization of vessels, blood flow, and tissue perfusion, along with extrahepatic biliary ducts. It comes with a 25 mg vial of SPY AGENT GREEN, sterile water for injection, two 3 mi syringes, two 18 G, 1-inch needles, labels for syringes, one SPY-MIS kit IFU, and one SPY AGENT GREEN (indocyanine green for injection, USP) package insert. The components of the kit, excluding packaging, are sterile. The SPY AGENT GREEN must be reconstituted with accompanying sterile water diluent before use and must be used within six hours of reconstitution. The item should be stored at 20°C to 25°C (68°F to 77°F). This product is manufactured by Novadaq Technologies ULC and distributed by Stryker.*

The SPY-PHI pack contains six kits with SPY AGENT™ GREEN, which is used with the SPY-PHI System to visualize blood flow, vessels, and tissue perfusion. Each kit includes one 25 mg vial of lyophilized, sterile SPY AGENT™ GREEN and one 10 mL vial of sterile water for injection, among other components. The SPY AGENT™ GREEN vial should be reconstituted before use, and each kit is only to be used once. The product is manufactured and distributed by Novadaq Technologies and Carestream Health, respectively. The lot and use-by date are provided for each kit, and the product should be stored at 20°C to 25°C until use.*

The SPY-PHI Pack is a kit for use with the SPY-PHI System that is intended for the visualization of vessels, blood flow, and tissue perfusion. The kit contains 25mg of SPY AGENT GREEN (indocyanine green for injection, USP) per vial, which needs to be reconstituted with accompanying sterile water diluent before use. The SPY AGENT GREEN needs to be used within 6 hours of reconstitution. The kit is distributed by Carestream Health, Inc. and manufactured for Customer Supply by Novadaq Technologies ULC. The kit needs to be stored at 20°C to 25°C (68°F to 77°F). *

The SPY-PHI Kit is a medical kit used for visualization of vessels, blood flow, and tissue perfusion with the SPY-PHI System. The kit includes a 25 mg vial of SPY AGENT™ GREEN (indocyanine green for injection, USP), a 10 mi vial of Sterile Water for Injection, USP, a SPY-PHI Drape (HH2000), sterile, and a SPY-PHI Kit IFU, among other components. The kit should be reconstituted with accompanying sterile water diluent before use and used within six hours of reconstitution. The outside packaging and tray are not sterile. The product is manufactured by Novadax Technologies ULC and distributed by Carestream Health Inc. Customer support is available toll-free.*

SPYAGENT GREEN is a sterile single dose vial of indocyanine green for injection, USP. Each vial contains 25mglvial. The medication should be discarded if any part remains unused after reconstitution. It is imperative to use the medication within 6 hours after reconstitution. Usual dosage is available in the prescribing information. Manufactured by Patheon ltalia S.p.A, and Distributed by: Novadaq Technologies ULC.*