Identity
- Trade Name
- Bio V BP Bioactive Glass with DBM Putty FDA UDI
- Generic Name
- Cadaveric-donor/synthetic mineral bone graft FDA UDI
- Device Name
- Synthetic bone void filler containing DBM for orthopedic applications, provided in a syringe dispenser FDA UDI
- Model / Reference
- BGP001-10 FDA UDI
- Description
- Synthetic bone void filler containing DBM for orthopedic applications, provided in a syringe dispenser FDA UDI
Identifiers
- Catalog Number
- BGP001-10 FDA UDI
- Primary DI / UDI-DI
- 00858686006072 FDA UDI
- FDA Product Code
- MBP FDA UDIMQV FDA UDI
- GMDN Term
- Cadaveric-donor/synthetic mineral 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
Yes
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 10.0 Milliliter FDA UDI
Category: Cadaveric-donor/synthetic mineral bone graft
Bio V BP Bioactive Glass with DBM Putty by Amend Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cadaveric-donor/synthetic mineral bone graft.
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- R-GENIN Strip — Berkeley Advanced Biomaterials · Class II
- B-GENIN Strip — Berkeley Advanced Biomaterials · Class II
- B-GENIN Strip — Berkeley Advanced Biomaterials · Class II
- B-GENIN Strip — Berkeley Advanced Biomaterials · Class II
- R-GENIN Strip — Berkeley Advanced Biomaterials · 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
- Amend Surgical, Inc.
Sources (1)
- FDA UDI e2a484b5-df94-4237-976c-888d5714af25 37 fields · synced May 30, 2026