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Offset neck pattern 8-M
EUDAMEDFDA UDIClass I (EU MDR)
Ref 112-A51508Ref 112-A56508Ref 112-A51508
Identity
- Trade Name
- Offset neck pattern 8-M EUDAMEDOffset neck pattern 8-M PLUS EUDAMEDTouch CMC 1 - Offset Neck Pattern 8-M FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- TOUCH Offset Neck Pattern EUDAMEDPatterns EUDAMED
- Model / Reference
- 112-A51508 EUDAMEDFDA UDI112-A56508 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640181160846 EUDAMEDFDA UDI07640181162956 EUDAMED
- Basic UDI-DI
- B-07640181160846 EUDAMED764018116015B7 EUDAMED
- PMA Number
- P240020 FDA UDI
- FDA Product Code
- SFA FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMEDClass III FDA UDI
- Market of Registration
- France 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
EUDAMEDEUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Offset neck pattern 8-M by Keri Medical SA — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07640181160846 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-07640181160846 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Keri Medical SA
- EUDAMED SRN
- CH-MF-000021960
- Authorised Representative
- Keri Medical France FR-AR-000009590
Sources (4)
- EUDAMED bda96123-4279-4298-9cba-9a0676df4193 61 fields · synced Jul 9, 2026
- EUDAMED bb1697d8-9449-4888-b4e0-67b6148bbf84 61 fields · synced May 19, 2026
- FDA UDI 49e74206-859a-4a45-bb96-3e34d89cca00 33 fields · synced May 30, 2026
- EUDAMED 50970cf6-1c8b-49e8-bd7e-fd68253a2503 61 fields · synced Jul 9, 2026