← Back to catalogue
Depuy Orthopaedic Instruments
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2294-53-130Model M.B.T. Sleeve Trial
Identity
- Trade Name
- DEPUY ORTHOPAEDIC INSTRUMENTS EUDAMEDNA FDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDI
- Device Name
- Sleeve Trial EUDAMEDUNIVERSAL REVISION FEMORAL SLEEVE TRIAL 40mm FDA UDI
- Model / Reference
- M.B.T. Sleeve Trial EUDAMED2294-53-130 EUDAMEDFDA UDI
- Description
- UNIVERSAL REVISION FEMORAL SLEEVE TRIAL 40mm FDA UDI
Identifiers
- Catalog Number
- 229453130 FDA UDI
- Primary DI / UDI-DI
- 10603295113751 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a005268Z EUDAMED
- Direct Marketing DI
- 10603295113751 EUDAMED
- FDA Product Code
- HWT FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical implant template, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4800 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
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
Depuy Orthopaedic Instruments 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 | 0603295a005268Z | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED 0665a556-589b-4cb8-afd5-e69ecb7c8f4d 61 fields · synced Jun 20, 2026
- FDA UDI 4db8bd87-d4e4-4e6b-8ba3-df22d17c3bf2 35 fields · synced May 30, 2026