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Right Double Offset Broach Handle - Enztec
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1080-0-1902Ref 4252-2312
Identity
- Trade Name
- Right Double Offset Broach Handle - Enztec EUDAMEDEnztec Handle EUDAMEDFDA UDI
- Generic Name
- Orthopaedic implant impactor, reusable FDA UDI
- Device Name
- Broach Handles EUDAMEDEnztec Cup Impactors EUDAMEDA reusable surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDI
- Model / Reference
- 1080-0-1902 EUDAMED4252-2312 EUDAMEDFDA UDI
- Description
- A reusable surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDI
Identifiers
- Catalog Number
- 4252-2312 FDA UDI
- Primary DI / UDI-DI
- 09421038411230 EUDAMED09421028118767 EUDAMEDFDA UDI
- Basic UDI-DI
- 942102811GMN0002ZS EUDAMED942102811GMN00092B EUDAMED
- Direct Marketing DI
- 09421038411230 EUDAMED09421028118767 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
Right Double Offset Broach Handle - Enztec 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 | 942102811GMN0002ZS | 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 (3)
- EUDAMED 15e57cf5-ca5e-4677-829a-ff050d2f88d9 61 fields · synced Jul 21, 2026
- FDA UDI aaccb1fc-c15f-404f-bc39-6de56b758c11 34 fields · synced May 30, 2026
- EUDAMED 93c4692d-aee3-4620-b8ef-511d04228b43 61 fields · synced Jul 21, 2026