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Bone Cement - Normal Viscosity
FDA UDIClass II (US FDA UDI)
by Biomecânica Indústria e Comércio de Produtos Ortopédicos Ltda.
Identity
- Trade Name
- Bone Cement - Normal Viscosity FDA UDI
- Generic Name
- Orthopaedic cement, non-antimicrobial FDA UDI
- Device Name
- https://www.biomecanica.com.br/instrucoes-de-uso/ FDA UDI
- Model / Reference
- Bone Cement - Normal Viscosity FDA UDI
- Description
- https://www.biomecanica.com.br/instrucoes-de-uso/ FDA UDI
Identifiers
- Catalog Number
- 2005-00-000 FDA UDI
- Primary DI / UDI-DI
- 07898315500901 FDA UDI
- 510(k) Number
- K212729 FDA UDI
- FDA Product Code
- LOD FDA UDI
- GMDN Term
- Orthopaedic cement, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3027 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: Orthopaedic cement, non-antimicrobial
Bone Cement - Normal Viscosity by Biomecânica Indústria e Comércio de Produtos Ortopédicos Ltda. — Class II — FDA UDI — listed in FDA GUDID
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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
Sources (1)
- FDA UDI 1a15dc20-c12d-43d1-8d3d-c21affaa35f1 35 fields · synced May 31, 2026