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Depuy Synthes
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 1294-54-120Model MBT Revision Porous Sleeves
Identity
- Trade Name
- DEPUY SYNTHES EUDAMEDNA FDA UDI
- Generic Name
- Knee arthroplasty wedge FDA UDI
- Device Name
- Porous Sleeves EUDAMEDM.B.T. REVISION METAPHYSEAL SLEEVE POROUS 53mm FDA UDI
- Model / Reference
- MBT Revision Porous Sleeves EUDAMED1294-54-120 EUDAMEDFDA UDI
- Description
- M.B.T. REVISION METAPHYSEAL SLEEVE POROUS 53mm FDA UDI
Identifiers
- Catalog Number
- 129454120 FDA UDI
- Primary DI / UDI-DI
- 10603295026433 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a0043893 EUDAMED
- FDA Product Code
- NJL FDA UDI
- EMDN Code
- P09098002 KNEE PROSTHESES ADAPTERS (INCLUDING CONES AND SLEEVES) EUDAMED
- GMDN Term
- Knee arthroplasty wedge FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass III FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Knee arthroplasty wedge
Depuy Synthes by DePuy Ireland UC — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Knee arthroplasty wedge.
- NexGen® — Zimmer, Inc. · Class II
- ADVANCE® — MicroPort Orthopedics Inc. · Class II
- 3DMetal Diaphyseal Femoral Cones — Medacta International · Class II
- LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG · Class II
- LEGION — Smith & Nephew, Inc. · Class II
- ADVANTIM® — MicroPort Orthopedics Inc. · Class II
- LinkSymphoKnee — WALDEMAR LINK GmbH & Co. KG · Class II
- Unity Total Knee System — CORIN LTD · Class II
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 | 0603295a0043893 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED f2faee51-54a2-45ce-a0ef-bd1d31e5f4c6 61 fields · synced Jul 12, 2026
- FDA UDI 5bfa902d-0df5-4638-b6c7-618fe6862638 35 fields · synced May 30, 2026