Product code PFC
- Device name
- Cultured Human Cell Skin Dressing
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Allogeneic skin cells cultured in vitro and combined with scaffold sheeting to act as a physical wound covering and provide biological components that interact with the wound, for treatment of skin ulcers.
- Source
- FDA openFDA device classification dataset