Identity
- Trade Name
- CEMEX GENTA SYSTEM FAST 70G FDA UDI
- Generic Name
- Orthopaedic cement preparation/delivery kit FDA UDI
- Device Name
- Cemex Genta System Fast 70g is an antibiotic-loaded polymethylmethacrylate bone cement. Cemex Genta System Fast 70g holds the powder (70g) and liquid (29,3g) components separately within a closed syringe-like device that serves as both a mixing chamber and a cement delivery system. The device is supplied sterile, for single use. Cemex Genta System Fast 70g 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
- 13A2101 US FDA UDI
- Description
- Cemex Genta System Fast 70g is an antibiotic-loaded polymethylmethacrylate bone cement. Cemex Genta System Fast 70g holds the powder (70g) and liquid (29,3g) components separately within a closed syringe-like device that serves as both a mixing chamber and a cement delivery system. The device is supplied sterile, for single use. Cemex Genta System Fast 70g 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
- 28031497000538 FDA UDI
- FDA Product Code
- MBB FDA UDILOD FDA UDI
- GMDN Term
- Orthopaedic cement preparation/delivery kit 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
No
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 preparation/delivery kit
Cemex Genta System Fast 70g by Tecres — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic cement preparation/delivery kit.
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- LITe BIO Delivery System — Stryker Corp. · Class II
- VORTEX — Smith & Nephew, Inc. · Class I
- StabiliT® — Merit Medical Systems, Inc. · Class II
- PicoMix Bowl — G21 SRL · Class I
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
- Tecres
Sources (1)
- FDA UDI c9d2a055-a5d8-4de6-b90b-0a21beaddff6 33 fields · synced Jun 8, 2026