Identity
- Trade Name
- NanoBone® SBX Putty FDA UDI
- Generic Name
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
- Device Name
- Synthetic biodegradable bone graft substitute consisting of NanoBone® | granulate (non-sintered nanocrystalline hydroxyapatite in a porous silica gel matrix) embedded in an aqueous gel FDA UDI
- Model / Reference
- 200040 FDA UDI
- Description
- Synthetic biodegradable bone graft substitute consisting of NanoBone® | granulate (non-sintered nanocrystalline hydroxyapatite in a porous silica gel matrix) embedded in an aqueous gel FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14260418440406 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
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
- Total Volume — 0.25 Milliliter FDA UDI
Category: Bone matrix implant, synthetic, non-antimicrobial
NanoBone® SBX Putty by Biocomposites Ltd — 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
- Biocomposites Ltd
Sources (1)
- FDA UDI 79375d13-5fe9-4e0d-ae1a-60656c321ef0 36 fields · synced Jun 8, 2026