Identity
- Trade Name
- GENTAFIX FDA UDI
- Generic Name
- Orthopaedic cement, antimicrobial FDA UDI
- Model / Reference
- 3 FDA UDI
Identifiers
- Catalog Number
- T040340G FDA UDI
- Primary DI / UDI-DI
- 03760177040137 FDA UDI
- FDA Product Code
- LOD FDA UDIMBB FDA UDI
- GMDN Term
- Orthopaedic cement, 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
MR Safe FDA UDI
Category: Orthopaedic cement, antimicrobial
Gentafix by Teknimed — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic cement, antimicrobial.
- BonOs HV Genta — OSARTIS GmbH · Class II
- PALACOS® — Heraeus Medical LLC · Class II
- Refobacin® Bone Cement R — Biomet, Inc. · Class II
- Unite Cement — OSTEOREMEDIES, LLC · Class II
- MectaCem-X LV with Gentamicin — Tecres · Class II
- BRAVO MV+G — G21 SRL · Class II
- Simplex — Howmedica Osteonics Corp. · Class II
- Cemex Genta HV — Tecres · 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 |
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Manufacturer
- Manufacturer
- Teknimed
Sources (1)
- FDA UDI 613315cb-18eb-4389-9f65-6fc1f4b2d289 34 fields · synced May 30, 2026