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Self-Centering
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2055-12-000Model TISSUE SPARING SOLUTIONS Instrument Handle
Identity
- Trade Name
- SELF-CENTERING EUDAMEDSELF CENTERING FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- Instrument Handle EUDAMEDSELF CENTERING MODULAR CATHCART HANDLE STRAIGHT FDA UDI
- Model / Reference
- TISSUE SPARING SOLUTIONS Instrument Handle EUDAMED2055-12-000 EUDAMEDFDA UDI
- Description
- SELF CENTERING MODULAR CATHCART HANDLE STRAIGHT FDA UDI
Identifiers
- Catalog Number
- 205512000 FDA UDI
- Primary DI / UDI-DI
- 10603295084471 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a004889J EUDAMED
- Direct Marketing DI
- 10603295084471 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, reusable 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
Self-Centering 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 | 0603295a004889J | 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 296305ab-1171-4305-9995-a1a96611618d 61 fields · synced Aug 1, 2026
- FDA UDI 8c37cc82-ffd8-4e7a-bf05-6da282ad011e 35 fields · synced May 29, 2026