Identity
- Trade Name
- CEMENT PRESSURIZER FDA UDI
- Generic Name
- Orthopaedic cement compressor FDA UDI
- Device Name
- Cement Pressurizer is intended to be used in cemented arthroplasty for the pressurization of the cement inside the femoral canal during retrograde filling. FDA UDI
- Model / Reference
- PRZ-01 FDA UDI
- Description
- Cement Pressurizer is intended to be used in cemented arthroplasty for the pressurization of the cement inside the femoral canal during retrograde filling. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08031497002248 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic cement compressor FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
No
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
Yes
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 compressor
Cement Pressurizer by Tecres — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Titan™ — Ascension Orthopedics, Inc. · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Tecres
Sources (1)
- FDA UDI de6d6472-a6b0-49a9-bba4-0b20acc4ca79 33 fields · synced Jun 6, 2026