Figure 1 (Gintuit Figure1)
Gintuit
Product Images NDC 42606-004
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Gintuit (NDC 42606-004). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Organogenesis, 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.
Product Images & Figures Index
Figure 2 (Gintuit Figure2)
Figure 3 (Gintuit Figure3)
Figure 4 (Gintuit Figure4)
Figure 5 (Gintuit Figure5)
Figure 6 (Gintuit Figure6)
Figure 7 (Gintuit Figure7)
Figure 8 (Gintuit Figure8)
Instruction (Instr)
This is a set of instructions and guidelines for the handling and storage of Gintuit™, a product that contains allogeneic cultured keratinocytes and fibroblasts in bovine collagen. Before using Gintuit™, it is important to check the pH of the agarose gel medium and the expiration date. If there is any damage or evidence of an expired or out-of-range product, a replacement should be arranged promptly. The polybag that contains the product should not be opened until the clinician is ready to apply it to the patient. Gintuit™ must be used within 15 minutes of opening the polybag, and should be kept in its shipping box at 68°F to 73°F until ready for application.*
Label (Label)
The bag contains a single unit of a 75 mm diameter cellular sheet consisting of human keratinocyte and fibroblast cells, human extracellular matrix proteins, and bovine collagen. It's a product for topical oral application which should not be refrigerated or frozen. The color of the agarose gel medium should be compared with the Agarose Gel Medium pH Chart to ensure its quality. Also, the product should be used within 15 minutes of opening and shouldn't be used past its expiry date. The manufacturer warns not to use it in patients with known allergies to bovine collagen.*
Ph Color Chart (Ph Color Chart)
This document contains instructions for the use of allogeneic cultured keratinocytes and fibroblasts in bovine collagen, as well as a pH chart for the agarose gel medium used in the product. If the pH of the medium is outside of the acceptable range, do not use the product. For technical inquiries, a phone number is provided. The document is copyrighted by Organogenesis Inc.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
