Identity
- Trade Name
- MectaCem-X HV with Gentamicin FDA UDI
- Generic Name
- Orthopaedic cement, antimicrobial FDA UDI
- Device Name
- MectaCem-X HV with Gentamicin is a low viscosity antibiotic-loaded polymethylmethacrylate bone cements. It is composed by two components (40g powder and 14,7g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. MectaCem-X HV with Gentamicin is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. FDA UDI
- Model / Reference
- 65.01.111US FDA UDI
- Description
- MectaCem-X HV with Gentamicin is a low viscosity antibiotic-loaded polymethylmethacrylate bone cements. It is composed by two components (40g powder and 14,7g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. MectaCem-X HV with Gentamicin is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08031497002163 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
Yes
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
Category: Orthopaedic cement, antimicrobial
MectaCem-X HV with Gentamicin by Tecres — 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
- BRAVO MV+G — G21 SRL · Class II
- Simplex — Howmedica Osteonics Corp. · Class II
- PALACOS® — Heraeus Medical LLC · Class II
- REFOBACIN® BONE CEMENT R — Biomet, 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
- Tecres
Sources (1)
- FDA UDI 413b561d-0ece-4485-9ed9-eaf73f62dccc 33 fields · synced Jun 8, 2026