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Corail Revision
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref L98516Model C-STEM AMT Femoral Stem Trial Prosthesis, HipRef 2274-36-000Model Summit Depth Gauge
Identity
- Trade Name
- CORAIL REVISION EUDAMEDCORAIL EUDAMEDFDA UDINA FDA UDI
- Generic Name
- Surgical depth gauge, reusable FDA UDIFemoral stem prosthesis trial FDA UDI
- Device Name
- Femoral Stem Trial Prosthesis, Hip EUDAMEDDEPTH GAUGE EUDAMEDFDA UDICORAIL HIP SYSTEM CORAIL REVISION TRIAL STEM,SIZE 16 FDA UDI
- Model / Reference
- C-STEM AMT Femoral Stem Trial Prosthesis, Hip EUDAMEDL98516 EUDAMEDFDA UDI2274-36-000 EUDAMEDFDA UDISummit Depth Gauge EUDAMED
- Description
- DEPTH GAUGE FDA UDICORAIL HIP SYSTEM CORAIL REVISION TRIAL STEM,SIZE 16 FDA UDI
Identifiers
- Catalog Number
- 227436000 FDA UDIL98516 FDA UDI
- Primary DI / UDI-DI
- 10603295262640 EUDAMEDFDA UDI10603295109198 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a000718D EUDAMED0603295a004869E EUDAMED
- Direct Marketing DI
- 10603295262640 EUDAMED10603295109198 EUDAMED
- FDA Product Code
- HTJ FDA UDIHWT FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMEDL091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED
- GMDN Term
- Surgical depth gauge, reusable FDA UDIFemoral stem prosthesis trial FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDFDA UDI
- Regulation Number
- 888.4300 FDA UDI888.4800 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
No
EUDAMEDEUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMEDEUDAMED
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 IIa — 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 | 0603295a000718D | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (4)
- EUDAMED 4d84f457-9365-465a-a927-41ba0d4cbff5 61 fields · synced Aug 2, 2026
- FDA UDI 5432c527-6f56-4703-ab8f-d86464f3cdb6 35 fields · synced May 30, 2026
- FDA UDI b61d3012-5edd-48ab-833d-39b992547b6a 35 fields · synced May 30, 2026
- EUDAMED 0c03192c-6d0a-4ff9-99eb-eda77a472ac7 61 fields · synced Jul 21, 2026