Identity
- Trade Name
- Bio-Reign 3D FDA UDI
- Generic Name
- Synthetic bone graft FDA UDI
- Device Name
- Bio-Reign 3D Sheet 25mm x 50mm x 3mm FDA UDI
- Model / Reference
- BR-s25x50x3 FDA UDI
- Description
- Bio-Reign 3D Sheet 25mm x 50mm x 3mm FDA UDI
Identifiers
- Catalog Number
- BR-s25x50x3 FDA UDI
- Primary DI / UDI-DI
- 00850014593704 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
Yes
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
Bio-Reign 3D by Royal Biologics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Royal Biologics, Inc.
Sources (1)
- FDA UDI 5a394a4a-2d26-4e6f-8e39-a6ad9038cd7c 36 fields · synced May 30, 2026