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Sp2
EUDAMEDFDA UDIClass I (EU MDR)
Ref 9505-01-029Model SP2 Cutting Guides, Blocks and Stops, Knee
Identity
- Trade Name
- SP2 EUDAMEDNA FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Cutting Guides, Blocks and Stops, Knee EUDAMEDSP2 MI FEMORAL CHAMFER CUT BLOCK 4 FDA UDI
- Model / Reference
- SP2 Cutting Guides, Blocks and Stops, Knee EUDAMED9505-01-029 EUDAMEDFDA UDI
- Description
- SP2 MI FEMORAL CHAMFER CUT BLOCK 4 FDA UDI
Identifiers
- Catalog Number
- 950501029 FDA UDI
- Primary DI / UDI-DI
- 10603295224310 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a003989G EUDAMED
- Direct Marketing DI
- 10603295224310 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
Sp2 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 0131bb10-8eca-4623-a0ab-683edf656474 61 fields · synced Jun 18, 2026
- FDA UDI 372d60ae-cc96-4b4e-b499-ff21857c6061 35 fields · synced May 30, 2026