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Marathon XLPE
EUDAMEDFDA UDIClass I (EU MDR)
Ref 9626-00-036Model PINNACLE Instrument/Implant Inserter, Hip
Identity
- Trade Name
- Marathon XLPE EUDAMEDNA FDA UDI
- Generic Name
- Hip prosthesis socket pusher FDA UDI
- Device Name
- Instrument/Implant Inserter, Hip EUDAMEDMarathon XLPE Cemented Cup 36mm Introducer FDA UDI
- Model / Reference
- PINNACLE Instrument/Implant Inserter, Hip EUDAMED9626-00-036 EUDAMEDFDA UDI
- Description
- Marathon XLPE Cemented Cup 36mm Introducer FDA UDI
Identifiers
- Catalog Number
- 962600036 FDA UDI
- Primary DI / UDI-DI
- 10603295243267 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a0039294 EUDAMED
- FDA Product Code
- HWR FDA UDI
- EMDN Code
- L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED
- GMDN Term
- Hip prosthesis socket pusher 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
Category: Orthopaedic implant impactor, reusable
Marathon XLPE by DePuy Ireland UC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic implant impactor, reusable.
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- R3 — Smith & Nephew, Inc. · Class I
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 | 0603295a0039294 | 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 8ced8d6c-765a-4235-9a38-c556bcc83453 61 fields · synced Jun 18, 2026
- FDA UDI 76b6ae79-ab4a-46fa-bfcc-c2e43b962627 35 fields · synced May 30, 2026