ASCENT FLEXXPRP
- Primary DI
- G668FG0011
- Brand
- ASCENT FLEXXPRP
- Company
- ORTHOASCENT, LLC
- Model
- FG-001 Platelet Rich Plasma (PRP)
- Device description
- The Platelet Rich Plasma (PRP) Device is a single-use, sterile concentrating device. It concentrates blood components and aids in the separation of the blood components by density using a centrifuge. The PRP prepared by this device has not been evaluated for any clinical indications. The PRP prepared by this device is NOT indicated for delivery to the patient’s circulatory system.
- Published
- 2026-01-05
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| ORG | Platelet And Plasma Separator For Bone Graft Handling |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| ORG | Platelet And Plasma Separator For Bone Graft Handling | Hematology | 2 |
Premarket Submissions
| Submission | Supplement |
|---|
| BK241083 | 0 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| BK241083 | 0 | | | | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| G668FG0010 | Primary | HIBCC | 0 | |
| G668FG0011 | Unit of Use | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Autologous platelet-based product centrifuge tube | A small, cylindrical container intended to temporarily store venous blood and subsequently placed in a centrifuge to produce platelet rich fibrin (PRF) or platelet rich plasma (PRP) for application to the patient from whom the blood was taken (typically for mixing with bone graft to repair bone defects and/or application to skin wounds to accelerate healing and/or achieve haemostasis). It typically includes a lid intended to be pierced with a syringe needle for blood infusion and PRF/PRP withdrawal, clot activator (e.g., silica) and/or filter for isolation of the PRF/PRP, and a rotation mechanism facilitated by centrifugation. This is a single-use device. |
Regulatory Flags
- DUNS number
- 119273976
- Device count
- 8
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| G668FG0010 | ASCENT FLEXXPRP | FG-001 Platelet Rich Plasma (PRP) | | 2026-01-05 |
| G668FG0020 | ASCENT FLEXXBMC | FG-002 Bone Marrow Concentrate (BMC) | | 2026-01-05 |
| G668FG0021 | ASCENT FLEXXBMC | FG-002 Bone Marrow Concentrate (BMC) | | 2026-01-05 |
| G668FG0160 | BMC Device Masterpack | FG-016 BMC Device Masterpack | | 2026-01-05 |
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