Identity
- Trade Name
- CellFUSE™ FDA UDI
- Generic Name
- Synthetic bone graft FDA UDI
- Device Name
- CellFUSE™ Sheet 25mm x 125mm x 5mm FDA UDI
- Model / Reference
- CF-s25x125x5 FDA UDI
- Description
- CellFUSE™ Sheet 25mm x 125mm x 5mm FDA UDI
Identifiers
- Catalog Number
- CF-s25x125x5 FDA UDI
- Primary DI / UDI-DI
- 00850005961031 FDA UDI
- FDA Product Code
- MQV FDA UDI
- GMDN Term
- Synthetic bone graft FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3045 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Synthetic bone graft
A single-use artificial bone substitute used for structural bone replacement, typically when bone is lost due to disease or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive.
Similar devices
Also classified as Synthetic bone graft.
- Beta-bsm ® — Etex Corp. · Class II
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- Bicera® Resorbable Bone Substitute — Wiltrom Co., Ltd. (Chutung) · Class II
- OsseoSculpt Moldable ABG, 3cc — Biogennix, LLC · Class II
- Montage Settable Bone Putty — ABYRX, INC. · Class II
- IngeniOS HA — curasan AG · Class II
- Osbone Dental — curasan AG · Class II
- Bicera® Resorbable Bone Substitute — WILTROM INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Regenacell Therapy Inc
Sources (1)
- FDA UDI 07ec775d-9e4c-47c0-850a-4a5a99c7789a 34 fields · synced Jul 12, 2026