Identity
- Trade Name
- BIOGRAN® FDA UDI
- Generic Name
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
- Device Name
- 707020-F-BIOGRAN® 1500MG (CUP) CONTENTS: 7 STERILE 1500MG CUPS FDA UDI
- Model / Reference
- 2100-0005 FDA UDI
- Description
- 707020-F-BIOGRAN® 1500MG (CUP) CONTENTS: 7 STERILE 1500MG CUPS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00844868036111 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
- 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
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 1500 Milligram FDA UDI
Category: Bone matrix implant, synthetic, non-antimicrobial
Biogran® by Biomet 3i, Llc — 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
- Biomet 3i, Llc
Sources (1)
- FDA UDI 2ee6c54e-c256-4fbd-a60e-dcabbcb86ad0 35 fields · synced May 30, 2026