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Depuy Reach
EUDAMEDFDA UDIClass I (EU MDR)
Ref 9505-05-159Model SP2 Cutting Guides, Blocks and Stops, Knee
Identity
- Trade Name
- DEPUY REACH EUDAMEDFDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Cutting Guides, Blocks and Stops, Knee EUDAMEDDEPUY REACH TIBIAL CUTTING BLOCK 3 DEGREE FDA UDI
- Model / Reference
- SP2 Cutting Guides, Blocks and Stops, Knee EUDAMED9505-05-159 EUDAMEDFDA UDI
- Description
- DEPUY REACH TIBIAL CUTTING BLOCK 3 DEGREE FDA UDI
Identifiers
- Catalog Number
- 950505159 FDA UDI
- Primary DI / UDI-DI
- 10603295431077 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a003989G EUDAMED
- FDA Product Code
- HTZ FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
Depuy Reach 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 | 0603295a003989G | 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 451ef91e-1b12-4e82-a841-09445cda0571 61 fields · synced Jul 23, 2026
- FDA UDI 5a468482-0b8d-4653-b0a3-268f718e5761 35 fields · synced May 30, 2026