Identity
- Trade Name
- CEMEX ISOPLASTIC FDA UDI
- Generic Name
- Orthopaedic cement, non-antimicrobial FDA UDI
- Device Name
- Cemex Isoplastic is a high viscosity polymethylmethacrylate bone cement. It is composed by two components (40g powder and 13.3g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. Cemex Isoplastic is indicated for the fixation of joint prosthesis implants to the host bone. FDA UDI
- Model / Reference
- 1200/I FDA UDI
- Description
- Cemex Isoplastic is a high viscosity polymethylmethacrylate bone cement. It is composed by two components (40g powder and 13.3g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. Cemex Isoplastic is indicated for the fixation of joint prosthesis implants to the host bone. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 28031497000033 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
No
FDA UDI
Category: Orthopaedic cement, non-antimicrobial
Cemex Isoplastic by Tecres — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Manufacturer
- Tecres
Sources (1)
- FDA UDI c0bd21d2-290f-4159-bcfe-c9d0f3994480 33 fields · synced May 30, 2026