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Depuy Synthes
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 1294-53-246Model Universal Porous Sleeves
Identity
- Trade Name
- DEPUY SYNTHES EUDAMEDNA FDA UDI
- Generic Name
- Knee arthroplasty wedge FDA UDI
- Device Name
- Porous Sleeves EUDAMEDUNIVERSAL FEMORAL SLEEVE FULL POROUS 46mm FDA UDI
- Model / Reference
- Universal Porous Sleeves EUDAMED1294-53-246 EUDAMEDFDA UDI
- Description
- UNIVERSAL FEMORAL SLEEVE FULL POROUS 46mm FDA UDI
Identifiers
- Catalog Number
- 129453246 FDA UDI
- Primary DI / UDI-DI
- 10603295026365 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a004438U EUDAMED
- FDA Product Code
- NJL FDA UDIJWH 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
- Regulation Number
- 888.3560 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 | 0603295a004438U | 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 a06a1b51-4436-479b-82f2-7563d0062ef5 61 fields · synced May 30, 2026
- FDA UDI 16905214-af6d-4d95-925b-887eb274015f 35 fields · synced May 30, 2026