← Back to catalogue
BoneSync Fast-Setting Drillable Calcium Phosphate Cement, 1cc
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- BoneSync Fast-Setting Drillable Calcium Phosphate Cement, 1cc FDA UDI
- Generic Name
- Bone matrix implant, composite FDA UDI
- Device Name
- Fast-Setting Drillable Calcium Phosphate Cement FDA UDI
- Model / Reference
- 21003-04 FDA UDI
- Description
- Fast-Setting Drillable Calcium Phosphate Cement FDA UDI
Identifiers
- Catalog Number
- ABS-3101 FDA UDI
- Primary DI / UDI-DI
- 00812337020435 FDA UDI
- FDA Product Code
- MQV FDA UDIOIS FDA UDI
- GMDN Term
- Bone matrix implant, composite 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
Yes
FDA UDI
Category: Bone matrix implant, composite
BoneSync Fast-Setting Drillable Calcium Phosphate Cement, 1cc by Dsm Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone matrix implant, composite.
- nanOss Loaded Advanced Bone Graft Substitute Kit — Xtant Medical Holdings, Inc. · Class II
- Vitoss — Stryker Corp. · Class II
- STRATOFUSE Strip — Berkeley Advanced Biomaterials · Class II
- OptiFuse Bi-Ostetic Foam Strip — Berkeley Advanced Biomaterials · Class II
- AlexiFuse Synthetic Foam Strip — Berkeley Advanced Biomaterials · Class II
- BiSyntek Putty — Berkeley Advanced Biomaterials · Class II
- MacroFORM Bioactive Packable Graft 5.0cc — NovaBone Products, LLC · Class II
- nanOss 3D Plus Advanced Bone Graft Substitute — Xtant Medical Holdings, Inc. · 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
- Dsm Biomedical, Inc.
Sources (1)
- FDA UDI de8ad084-89d2-4714-ab07-a2fe84255612 34 fields · synced Jun 1, 2026