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28mm Polarcup Unipolar Conversion +8mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 35130045
Identity
- Trade Name
- 28mm Polarcup Unipolar Conversion +8mm 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
- 35130045 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
- 35130045 FDA UDI
- Primary DI / UDI-DI
- 09421028112895 EUDAMEDFDA UDI
- Basic UDI-DI
- 942102811GMN00262B EUDAMED
- Direct Marketing DI
- 09421028112895 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
28mm Polarcup Unipolar Conversion +8mm 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 c6a3ea80-f26a-4738-8f47-05e682b53ce1 61 fields · synced Jun 18, 2026
- FDA UDI 6eb49fee-6820-4f8f-9eba-287d47cc27ca 34 fields · synced May 30, 2026