| Product NDC: | 42606-004 |
| Proprietary Name: | GINTUIT |
| Non Proprietary Name: | Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen |
| Active Ingredient(s): | /; /; / & nbsp; Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen |
| Administration Route(s): | TOPICAL |
| Dosage Form(s): | CELLULAR SHEET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 42606-004 |
| Labeler Name: | Organogenesis, Inc |
| Product Type: | CELLULAR THERAPY |
| FDA Application Number: | BLA125400 |
| Marketing Category: | BLA |
| Start Marketing Date: | 20120315 |
| Package NDC: | 42606-004-01 |
| Package Description: | 44.2 cm2 in 1 TRAY (42606-004-01) |
| NDC Code | 42606-004-01 |
| Proprietary Name | GINTUIT |
| Package Description | 44.2 cm2 in 1 TRAY (42606-004-01) |
| Product NDC | 42606-004 |
| Product Type Name | CELLULAR THERAPY |
| Non Proprietary Name | Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen |
| Dosage Form Name | CELLULAR SHEET |
| Route Name | TOPICAL |
| Start Marketing Date | 20120315 |
| Marketing Category Name | BLA |
| Labeler Name | Organogenesis, Inc |
| Substance Name | BOVINE TYPE I COLLAGEN; FORESKIN FIBROBLAST (NEONATAL); FORESKIN KERATINOCYTE (NEONATAL) |
| Strength Number | |
| Strength Unit | /; /; / |
| Pharmaceutical Classes | Allogeneic Cultured Cell Scaffold [EPC],Collagen [Chemical/Ingredient],Allogeneic Cultured Cell Scaffold [EPC],Tissue Scaffolds [Chemical/Ingredient],Cells, Cultured, Allogeneic [Chemical/Ingredient],Fibroblasts [Chemical/Ingredient],Allogeneic Cultured Cell Scaffold [EPC],Tissue Scaffolds [Chemical/Ingredient],Cells, Cultured, Allogeneic [Chemical/Ingredient],Keratinocytes [Chemical/Ingredient] |