Dermagraft 1
Dermagraft 1 is a Class III device made by Organogenesis Inc., listed under FDA premarket submission BP003600 and listed in FDA GUDID since 24 Sep 2014 (UDI-DI 00618474000015), active as of 23 Oct 2026.
Active
PMA
Valid until
No expiry
FDA recalls
None found
Documents
PMA BP003600
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00618474000015 | Date24 Sep 2014 | StatusListed |
| United States | FDA PMA | NumberBP003600 | Date— | StatusActive |
Official records
- AccessGUDID record 00618474000015
Across registries
- FDA premarket submission BP003600 Active
- FDA GUDID UDI-DI 00618474000015 listed 24 Sep 2014 Listed
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Dermagraft
- Generic name
- Skin regeneration template, human-/animal-derived
- Model / reference
- 1
- Primary DI / UDI-DI
- 00618474000015
- FDA product code
- PFC
- GMDN term
- Skin regeneration template, human-/animal-derived
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution