Identity
- Trade Name
- 63x28mm Locking Polarcup Trial EUDAMEDFDA UDI
- Generic Name
- Acetabulum prosthesis trial, prefabricated, reusable FDA UDI
- Device Name
- Trials EUDAMEDA surgical instrument representative of the definitive implant, intended to be used during an orthopaedic surgical procedure to assist in the selection of the correct size and/or position of the definitive implant. FDA UDI
- Model / Reference
- 35130039 EUDAMEDFDA UDI
- Description
- A surgical instrument representative of the definitive implant, intended to be used during an orthopaedic surgical procedure to assist in the selection of the correct size and/or position of the definitive implant. FDA UDI
Identifiers
- Catalog Number
- 35130039 FDA UDI
- Primary DI / UDI-DI
- 09421028112833 EUDAMEDFDA UDI
- Basic UDI-DI
- 942102811GMN00262B EUDAMED
- Direct Marketing DI
- 09421028112833 EUDAMED
- FDA Product Code
- HWT FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Acetabulum prosthesis trial, prefabricated, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
63x28mm Locking Polarcup Trial by Enztec Limited — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 942102811GMN00262B | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Enztec Limited
- EUDAMED SRN
- NZ-MF-000002264
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 550d499f-4a70-44ab-ac54-7097c1e98b7d 61 fields · synced Jul 9, 2026
- FDA UDI 4bc9c978-77a9-445a-b179-4f29994b88d2 34 fields · synced May 29, 2026