Identity
- Trade Name
- Stem holder EUDAMEDTouch CMC 1 - Stem holder FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Holders EUDAMED
- Model / Reference
- 112-A32000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640181160914 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018116020AY EUDAMED
- Direct Marketing DI
- 07640181160914 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
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
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
No
Manufacturing Date
Yes
Category: Orthopaedic surgical procedure kit, non-medicated, reusable
Touch CMC 1 - Stem holder by Keri Medical SA — Class III — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
P240020 also covers:
- TOUCH® CMC 1 — Keri Medical SA
- TOUCH® CMC 1 — Keri Medical SA
- TOUCH® CMC 1 — Keri Medical SA
- TOUCH® CMC 1 — Keri Medical SA
- Touch CMC 1 - Bone Awl — Keri Medical SA
- Touch CMC 1 - Cannulated Conical Reamer Ø9 — Keri Medical SA
- Touch CMC 1 - Cannulated Trapezium Starter — Keri Medical SA
- Touch CMC 1 - Kirschner wire — Keri Medical SA
- Touch CMC 1 - Kirschner wire Tube 16 cm Ø12mm — Keri Medical SA
- Touch CMC 1 - Metacarpal INTL rack lid — Keri Medical SA
- Touch CMC 1 - Metacarpal Rasp 0 — Keri Medical SA
- Touch CMC 1 - Metacarpal Rasp 1 — Keri Medical SA
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Keri Medical SA
Sources (2)
- FDA UDI fb6007dc-24a1-4e0f-9143-e25d769a11f5 33 fields · synced Jul 9, 2026
- EUDAMED f3acdc5e-06bc-4e0b-974d-f742fae7ad53 61 fields · synced Jul 9, 2026