Identity
- Trade Name
- MBCP FDA UDI
- Generic Name
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
- Device Name
- Synthetic Resorbable Bone Graft Granules FDA UDI
- Model / Reference
- 1301G550 FDA UDI
- Description
- Synthetic Resorbable Bone Graft Granules FDA UDI
Identifiers
- Catalog Number
- 1301G550 FDA UDI
- Primary DI / UDI-DI
- 03700501807760 FDA UDI
- 510(k) Number
- K051885 FDA UDI
- FDA Product Code
- LYC FDA UDI
- GMDN Term
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3930 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
Mbcp by Biomatlante — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K051885 also covers:
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
- Biomatlante
Sources (1)
- FDA UDI 30b114c2-d7bd-46e9-a7ac-d260b3fe4fe1 37 fields · synced Jun 1, 2026