ORG — Platelet And Plasma Separator For Bone Graft Handling Class II
FDA product code ORG covers "Platelet And Plasma Separator For Bone Graft Handling", a Class II medical device regulated under 21 CFR 864.9245. Submissions are reviewed by the Hematology panel.
Classification Details
- Product Code
- ORG
- Device Class
- Class II
- Regulation Number
- 864.9245
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Definition
Preparation of autologous platelet rich plasma from a small sample of peripheral blood for mixing with bone graft to improve handling characteristics.