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OCI X T-Handle Driver - S+N
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 4252-2302Ref 4252-2314
Identity
- Trade Name
- OCI X T-Handle Driver EUDAMEDFDA UDIOCI Handle+ EUDAMEDOCI X T-Handle Driver - S+N 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
- 4252-2314 EUDAMEDFDA UDI4252-2302 EUDAMED4252-2325 FDA UDI
- Description
- A reusable surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDI
Identifiers
- Catalog Number
- 4252-2325 FDA UDI4252-2314 FDA UDI
- Primary DI / UDI-DI
- 09421028118262 EUDAMEDFDA UDI09421028116664 EUDAMED09421038410349 FDA UDI
- Basic UDI-DI
- 942102811GMN00092B EUDAMED
- Direct Marketing DI
- 09421028116664 EUDAMED09421028118262 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
- Italy 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 X T-Handle Driver - S+N by Enztec Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Orthopaedic implant impactor, reusable.
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- KMEDIC — TELEFLEX INCORPORATED · Class I
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- R3 — Smith & Nephew, Inc. · Class I
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 (4)
- FDA UDI 8efb41e0-1cca-4ea6-b57a-ce97b38209e5 34 fields · synced Jul 30, 2026
- FDA UDI 8ab2094c-5d0d-432e-8b9e-92f90efb2ab9 34 fields · synced May 30, 2026
- EUDAMED 3a418673-affe-476d-943c-4bc158f9cd98 61 fields · synced Jul 10, 2026
- EUDAMED 41e6c2de-23fb-4907-9ca7-a86cf195b422 61 fields · synced Jul 30, 2026