Identity
- Trade Name
- Enztec Trinket M8x0.75-01 EUDAMEDFDA UDIOCI Trinket X M8X0.75-01 FDA UDI
- Generic Name
- Orthopaedic implant impactor, reusable FDA UDI
- Device Name
- Enztec Cup Impactors EUDAMEDA reusable surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDI
- Model / Reference
- 4252-2360 EUDAMEDFDA UDI4252-2340 FDA UDI
- Description
- A reusable surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDI
Identifiers
- Catalog Number
- 4252-2340 FDA UDI4252-2360 FDA UDI
- Primary DI / UDI-DI
- 09421028118866 EUDAMEDFDA UDI09421028118071 FDA UDI
- Basic UDI-DI
- 942102811GMN00092B EUDAMED
- FDA Product Code
- HWA FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic implant impactor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Spain 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
Category: Orthopaedic implant impactor, reusable
OCI Trinket X M8X0.75-01 by Enztec Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Enztec Limited
Sources (3)
- FDA UDI 567d576e-c370-4b68-bb0f-64ea39d7c5d5 34 fields · synced Jul 12, 2026
- FDA UDI 91cf76ce-7317-4499-998a-91a83ef1ad8e 34 fields · synced May 30, 2026
- EUDAMED 182dc504-0d33-410a-8dea-7bfd878f4bb0 61 fields · synced Jul 12, 2026