ASCENT FLEXXPRP FG-001 Platelet Rich Plasma (PRP)
by Orthoascent LLC GUDID
Listed (no authorization)
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberG668FG0010 | Date5 Jan 2026 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — GUDID listing Listed
Recalls
No FDA recalls on record, checked 23 Oct 2026.
Specification
- Trade Name
- Ascent Flexxprp
- Generic Name
- Autologous platelet-based product centrifuge tube
- Model / Reference
- FG-001 Platelet Rich Plasma (PRP)
- Primary DI / UDI-DI
- G668FG0010
- FDA Product Code
- ORG
- GMDN Term
- Autologous platelet-based product centrifuge tube
- Device Class
- Class II
- Regulation Number
- 864.9245
- Commercial Distribution
- In Commercial Distribution
Other devices from Orthoascent LLC
Properties
Other properties (8)
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No