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Enztec Femoral Impactor - Corin W Handle
EUDAMEDFDA UDIClass I (EU MDR)
Ref 4240-3089Ref 3991060
Identity
- Trade Name
- Enztec Femoral Impactor - Corin W Handle EUDAMEDFDA UDIHandle - Corin EUDAMED
- Generic Name
- Orthopaedic implant impactor, reusable FDA UDI
- Device Name
- Enztec Femoral Impactors EUDAMEDReamer Drivers and Acetabular Reamers EUDAMEDA reusable surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDI
- Model / Reference
- 4240-3089 EUDAMEDFDA UDI3991060 EUDAMED
- Description
- A reusable surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDI
Identifiers
- Catalog Number
- 4240-3089 FDA UDI
- Primary DI / UDI-DI
- 09421028116350 EUDAMEDFDA UDI09421028111775 EUDAMED
- Basic UDI-DI
- 942102811GMN0010ZR EUDAMED942102811GMN003022 EUDAMED
- Direct Marketing DI
- 09421028116350 EUDAMED09421028111775 EUDAMED
- FDA Product Code
- HWA FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMEDL0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic implant impactor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass IIa EUDAMED
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- France 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
Enztec Femoral Impactor - Corin W Handle 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 | 942102811GMN0010ZR | 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 539ebe0a-0355-4514-bcf9-453e57d5c675 61 fields · synced Aug 2, 2026
- FDA UDI 2c1f76f0-1ea1-4e3b-a4de-598db08ea224 34 fields · synced May 30, 2026
- EUDAMED 817cc932-3f81-41fc-8423-433892fa00a5 61 fields · synced Jul 18, 2026