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K-Wire Insert Monoaxial Drill Guide 3.5mm
EUDAMEDFDA UDIClass I (EU MDR)
Ref B-420031Model Bonebridge Instrument-Ir
Identity
- Trade Name
- K-Wire Insert Monoaxial Drill Guide 3.5mm EUDAMEDFDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Bonebridge Instrument-Ir EUDAMED
- Model / Reference
- Bonebridge Instrument-Ir EUDAMEDB-420031 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640187462326 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018746InstrumentsIrTM EUDAMED
- Direct Marketing DI
- 07640187462326 EUDAMED
- FDA Product Code
- FZX FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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 Insert Monoaxial Drill Guide 3.5mm 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 60674d7c-2989-4a2e-9456-9676f6d5c04a 61 fields · synced Aug 4, 2026
- FDA UDI 8eff289e-05e0-4e2d-a11a-43e3e2afc430 32 fields · synced May 30, 2026
- EUDAMED 1c3473f4-0b50-49c5-9593-a718f544ccd0 61 fields · synced Aug 4, 2026