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Power Tool TL Attachment 3.5mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref B-420002Model Bonebridge Instrument-IIa
Identity
- Trade Name
- Power Tool TL Attachment 3.5mm EUDAMEDFDA UDI
- Generic Name
- Surgical instrument torque limiter FDA UDI
- Device Name
- Bonebridge Instrument-IIa EUDAMED
- Model / Reference
- Bonebridge Instrument-IIa EUDAMEDB-420002 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640187461466 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018746InstrumentsIIa9G EUDAMED
- Direct Marketing DI
- 07640187461466 EUDAMED
- FDA Product Code
- HWE FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Surgical instrument torque limiter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 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
Power Tool TL Attachment 3.5mm 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 |
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Manufacturer
- Manufacturer
- Bonebridge AG
- EUDAMED SRN
- CH-MF-000013933
- Authorised Representative
- Axxos GmbH DE-AR-000005590
Sources (3)
- EUDAMED e41552bf-ebdd-48d4-b985-07920026a3e5 61 fields · synced Jul 31, 2026
- FDA UDI 43e3b9e5-6552-4269-96de-58b9a532533a 32 fields · synced May 30, 2026
- EUDAMED e1e23c0c-7ccc-48bf-8caa-664dcbfeb417 61 fields · synced Jul 31, 2026