Cut Guide
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- TRUMATCH FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
- Device Name
- Cut Guide EUDAMEDTRUMATCH PERSONALIZED SOLUTIONS RESECTION GUIDE FEMUR - CT KNEE FOR USE WITH: RIGHT FDA UDI
- Model / Reference
- Trumatch CT Cut Guide EUDAMED420918 EUDAMEDFDA UDI
- Description
- TRUMATCH PERSONALIZED SOLUTIONS RESECTION GUIDE FEMUR - CT KNEE FOR USE WITH: RIGHT FDA UDI
Identifiers
- Catalog Number
- 420918 FDA UDI
- Primary DI / UDI-DI
- 10603295384885 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a0056193 EUDAMED
- FDA Product Code
- NJL FDA UDIOOG FDA UDIJWH FDA UDI
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
Classification
- Device Class
- Class IIa 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Joint prosthesis implantation kit, single-use
Cut Guide by DePuy Ireland UC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0603295a0056193 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED 05106d9c-c6f0-487a-b048-ab3a9196632a 61 fields · synced Jul 30, 2026
- FDA UDI 1707f23c-1f8a-4ba4-a5b5-511b91d8ce71 35 fields · synced May 30, 2026