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Corail Revision
EUDAMEDFDA UDIClass I (EU MDR)
Ref L98414XModel CORAIL REVISION Femoral Broach, Hip
Identity
- Trade Name
- CORAIL REVISION EUDAMEDCORAIL FDA UDI
- Generic Name
- Orthopaedic broach FDA UDI
- Device Name
- Femoral Broach, Hip EUDAMEDCORAIL HIP SYSTEM CORAIL REVISION BROACH, SIZE 14 FDA UDI
- Model / Reference
- CORAIL REVISION Femoral Broach, Hip EUDAMEDL98414X EUDAMEDFDA UDI
- Description
- CORAIL HIP SYSTEM CORAIL REVISION BROACH, SIZE 14 FDA UDI
Identifiers
- Catalog Number
- L98414X FDA UDI
- Primary DI / UDI-DI
- 10603295394211 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a004708X EUDAMED
- Direct Marketing DI
- 10603295394211 EUDAMED
- FDA Product Code
- HTQ FDA UDI
- EMDN Code
- L091201 ORTHOPAEDIC SURGERY RASPS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic broach FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Ireland 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
Yes
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
Corail Revision by DePuy Ireland UC — 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 | 0603295a004708X | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED 0814aa53-200c-421a-bf9d-d9365827b985 61 fields · synced Jul 14, 2026
- FDA UDI e818a522-92dc-4cbb-8701-10e525a41e12 35 fields · synced May 30, 2026