Identity
- Trade Name
- KHEIRON EUDAMEDFDA UDI
- Generic Name
- Orthopaedic counter-torque/rod-pushing instrument FDA UDI
- Device Name
- Contre-couple pour tourne-écrou final EUDAMEDNut breaker counter torque FDA UDI
- Model / Reference
- 01CP4020 EUDAMEDFDA UDI
- Description
- Nut breaker counter torque FDA UDI
Identifiers
- Catalog Number
- 01CP4020 FDA UDI
- Primary DI / UDI-DI
- 03701313003166 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03701313003166 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic counter-torque/rod-pushing instrument FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Kheiron by S.m.a.i.o — 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-03701313003166 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- S.m.a.i.o
- EUDAMED SRN
- FR-MF-000002399
Sources (2)
- EUDAMED 44878ec3-9cf8-45ac-8921-bc75236dd4ff 61 fields · synced Jul 23, 2026
- FDA UDI 364a2fd1-3aab-4299-9d90-8467b2268430 35 fields · synced May 30, 2026