Identity
- Trade Name
- Straight neck pattern 6-S EUDAMEDTouch CMC 1 - Straight Neck Pattern 6-S FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- TOUCH Straight Neck Pattern EUDAMED
- Model / Reference
- 112-A50006 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640181160808 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07640181160808 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 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
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Straight neck pattern 6-S by Keri Medical SA — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07640181160808 | 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 (2)
- EUDAMED 123b44e9-978b-43e5-a51c-d28e0b226fba 61 fields · synced Jun 18, 2026
- FDA UDI c86d6422-47b1-4e59-92b4-08d53b4405d2 33 fields · synced May 30, 2026