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Specialist 2
EUDAMEDFDA UDIClass I (EU MDR)
Ref 96-6278Model TruMatch Cutting Block Position Guide
Identity
- Trade Name
- SPECIALIST 2 EUDAMEDSPECIALIST FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Cutting Block Position Guide EUDAMEDSPECIALIST 2 CHAMFER GUIDE WITH REMOVABLE HANDLE SZ 1.5 FDA UDI
- Model / Reference
- TruMatch Cutting Block Position Guide EUDAMED96-6278 EUDAMEDFDA UDI
- Description
- SPECIALIST 2 CHAMFER GUIDE WITH REMOVABLE HANDLE SZ 1.5 FDA UDI
Identifiers
- Catalog Number
- 966278 FDA UDI
- Primary DI / UDI-DI
- 10603295247623 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a005078V EUDAMED
- Direct Marketing DI
- 10603295247623 EUDAMED
- FDA Product Code
- HWT FDA UDI
- EMDN Code
- L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, 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
Category: Orthopaedic implant impactor, reusable
Specialist 2 by DePuy Ireland UC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 0603295a005078V | 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 90352cfd-f721-4a6f-9aec-26674ba7b509 61 fields · synced Jul 9, 2026
- FDA UDI 8acfdd2a-ef87-493a-aebc-7f5d07a001f2 35 fields · synced May 30, 2026