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K-Wire Ø1.4mm x 150mm
EUDAMEDFDA UDIClass I (EU MDR)
Ref B-410005Model Bonebridge Instrument-Ir
Identity
- Trade Name
- K-Wire Ø1.4mm x 150mm EUDAMEDFDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- Bonebridge Instrument-Ir EUDAMED
- Model / Reference
- Bonebridge Instrument-Ir EUDAMEDB-410005 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640187460605 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018746InstrumentsIrTM EUDAMED
- Direct Marketing DI
- 07640187460605 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- 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
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
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
K-Wire Ø1.4mm x 150mm by Bonebridge AG — 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 | 764018746InstrumentsIrTM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bonebridge AG
- EUDAMED SRN
- CH-MF-000013933
- Authorised Representative
- Axxos GmbH DE-AR-000005590
Sources (3)
- EUDAMED e7dd8165-2073-4c1b-b097-324020ee73a3 61 fields · synced Aug 3, 2026
- FDA UDI 6047b37e-f5b8-4e2c-b2e9-9a8080fcc434 32 fields · synced May 30, 2026
- EUDAMED 5c7f49d9-f936-4ad4-8702-12ad692fb328 61 fields · synced Aug 3, 2026