Identity
- Trade Name
- Polarcup Instrument Tray Base EUDAMEDFDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Instrument Trays EUDAMEDTray or case used to hold other medical devices FDA UDI
- Model / Reference
- 35130080 EUDAMEDFDA UDI
- Description
- Tray or case used to hold other medical devices FDA UDI
Identifiers
- Catalog Number
- 35130080 FDA UDI
- Primary DI / UDI-DI
- 09421028114820 EUDAMEDFDA UDI
- Basic UDI-DI
- 942102811GMN00352C EUDAMED
- Direct Marketing DI
- 09421028114820 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
No
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
Polarcup Instrument Tray Base by Enztec Limited — Class I — 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 | 942102811GMN00352C | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 8fefe549-3955-402f-a0e3-47220d1c8948 61 fields · synced Jul 19, 2026
- FDA UDI aaff77b5-188e-46e5-a9ff-7a59e482eaff 34 fields · synced May 30, 2026