FDA UDI
In Commercial Distribution
🇺🇸 United States
ASCENT FLEXXPRP
DI: G668FG0010
·
Model: FG-001 Platelet Rich Plasma (PRP)
·
ORTHOASCENT, LLC
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
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Basic Information
- Brand Name
- ASCENT FLEXXPRP
- Primary DI
- G668FG0010
- Version / Model
- FG-001 Platelet Rich Plasma (PRP)
- Company Name
- ORTHOASCENT, LLC
- Labeler DUNS
- 119273976
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-05
- Public Version
- 2
- Public Version Date
- 2026-02-27
- Public Version Status
- Update
- Public Device Record Key
- 94761785-9516-4876-863e-4ca55f6bff5a
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ORG | Platelet And Plasma Separator For Bone Graft Handling | Hematology | 864.9245 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61377 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G668FG0010 | HIBCC | ||||
| Package | G668FG0011 | HIBCC | Case | 8 | In Commercial Distribution | |
| Package | G668FG0012 | HIBCC | Case | 2 | In Commercial Distribution | |
| Package | G668FG0013 | HIBCC | Case | 4 | In Commercial Distribution | |
| Package | G668FG0014 | HIBCC | Case | 6 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK241083 | 0 |