Identity
- Trade Name
- OsteoCrete® Bone Void Filler FDA UDI
- Generic Name
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
- Device Name
- OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. OsteoCrete® Bone Void Filler 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
- 15cc FDA UDI
- Description
- OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. OsteoCrete® Bone Void Filler 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
- 44-150-00-BSI FDA UDI
- Primary DI / UDI-DI
- B4474415000BSI2 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
- 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
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
OsteoCrete® Bone Void Filler by Bone Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Bone Solutions, Inc.
Sources (1)
- FDA UDI 257f6aa6-e0dd-4560-b328-c5639e5a1d1c 37 fields · synced May 31, 2026