Product code ORG
- Device name
- Platelet And Plasma Separator For Bone Graft Handling
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.9245
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Preparation of autologous platelet rich plasma from a small sample of peripheral blood for mixing with bone graft to improve handling characteristics.
- Source
- FDA openFDA device classification dataset