Identity
- Trade Name
- BIOSORB FDA UDI
- Generic Name
- Synthetic bone graft FDA UDI
- Device Name
- Absorbable calcium salt bone void filler FDA UDI
- Model / Reference
- BIO1 Cubes FDA UDI
- Description
- Absorbable calcium salt bone void filler FDA UDI
Identifiers
- Catalog Number
- P822693220 FDA UDI
- Primary DI / UDI-DI
- 03760154000147 FDA UDI
- 510(k) Number
- K021963 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
- Not 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 0.26 Milliliter FDA UDIHeight — 5 Millimeter FDA UDILength — 5 Millimeter FDA UDIWidth — 5 Millimeter FDA UDI
Biosorb by S.b.m — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- S.b.m
Sources (1)
- FDA UDI 514f2ff8-7f92-43c8-be10-1cf6a8f87263 38 fields · synced May 30, 2026