← Back to catalogue
Drill Bit Ø3.5mm x 140mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref B-420019Model Bonebridge Instrument-IIa
Identity
- Trade Name
- Drill Bit Ø3.5mm x 140mm EUDAMEDDrill Bit Ø3.5mm x 110mm FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- Bonebridge Instrument-IIa EUDAMED
- Model / Reference
- Bonebridge Instrument-IIa EUDAMEDB-420019 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640187461688 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018746InstrumentsIIa9G EUDAMED
- Direct Marketing DI
- 07640187461688 EUDAMED
- FDA Product Code
- HTW 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 IIa EUDAMEDClass I FDA 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
Drill Bit Ø3.5mm x 140mm by Bonebridge AG — Class IIa — 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 | 764018746InstrumentsIIa9G | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bonebridge AG
- EUDAMED SRN
- CH-MF-000013933
- Authorised Representative
- Axxos GmbH DE-AR-000005590
Sources (3)
- EUDAMED 8078759c-5c86-49b0-aef4-078d1479f0c2 61 fields · synced Jul 24, 2026
- FDA UDI 504146b9-c5d2-4577-b653-ffa19305545c 32 fields · synced May 30, 2026
- EUDAMED 56c8f56d-c71d-44e8-b973-785a03ec08c1 61 fields · synced Jul 24, 2026