Identity
- Trade Name
- Opus Mg Set BVF FDA UDI
- Generic Name
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
- Device Name
- Opus Mg Set BVF is an injectable, moldable, and biocompatible Bone Void Filler. Opus Mg Set BVF Packet contains powder (Magnesium based compound) and a mixing solution (Buffered saline). It is a sterile, single use device, packaged with mixing and administration tools. FDA UDI
- Model / Reference
- 5cc FDA UDI
- Description
- Opus Mg Set BVF is an injectable, moldable, and biocompatible Bone Void Filler. Opus Mg Set BVF Packet contains powder (Magnesium based compound) and a mixing solution (Buffered saline). It is a sterile, single use device, packaged with mixing and administration tools. FDA UDI
Identifiers
- Catalog Number
- 712005 FDA UDI
- Primary DI / UDI-DI
- B4477120050 FDA UDI
- FDA Product Code
- MQV FDA UDI
- GMDN Term
- Bone matrix implant, synthetic, non-antimicrobial 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
Yes
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
Category: Bone matrix implant, synthetic, non-antimicrobial
Opus Mg Set BVF by Bone Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone matrix implant, synthetic, non-antimicrobial.
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft · Class II
- FIBERGRAFT BG Matrix — Prosidyan, Inc. · Class II
- MagnetOs — Kuros Biosciences B.V · Class II
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft · Class II
- NovoGro Putty — OSTEONOVUS, INC. · Class II
- PRO OSTEON 500 — Biomet Orthopedics, Inc. · Class II
- Syntricer — medArtis Medizinprodukte und Forschung Aktiengesellschaft · Class II
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bone Solutions, Inc.
Sources (1)
- FDA UDI 65709696-a5bf-44bc-a547-fb0af644a42b 35 fields · synced May 30, 2026