FDA UDI
In Commercial Distribution
🇺🇸 United States
ASCENT FLEXXBMC
DI: G668FG0020
·
Model: FG-002 Bone Marrow Concentrate (BMC)
·
ORTHOASCENT, LLC
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
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Basic Information
- Brand Name
- ASCENT FLEXXBMC
- Primary DI
- G668FG0020
- Version / Model
- FG-002 Bone Marrow Concentrate (BMC)
- 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
- d15784f1-75a2-46fd-8993-082f429b1603
Device Description
The FG-002 Bone Marrow Concentrate (BMC) Device is a single-use, sterile concentrating device. It concentrates autologous bone marrow aspirate using a centrifuge.
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
- Yes
- 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 |
|---|---|---|---|---|
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47153 | Haematological concentrate system preparation kit, bone marrow concentration | A collection of sterile devices typically used at the point-of-care for the rapid preparation of autologous bone marrow aspirate concentrate (BMAC) from bone marrow aspirate. The kit components, with the bone marrow aspirate, are directly placed in a dedicated centrifuge that separates and concentrates the bone marrow. The cellular BMAC preparations are typically applied to general and orthopaedic surgical sites, or pre-mixed with graft material, to assist the healing and/or graft acceptance process. The kit may include specimen drawing devices. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G668FG0020 | HIBCC | ||||
| Package | G668FG0021 | HIBCC | Case | 8 | In Commercial Distribution | |
| Package | G668FG0022 | HIBCC | Case | 2 | In Commercial Distribution | |
| Package | G668FG0023 | HIBCC | Case | 4 | In Commercial Distribution | |
| Package | G668FG0024 | HIBCC | Case | 6 | In Commercial Distribution |