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Depth Gauge 3.5mm L10 - L60
EUDAMEDFDA UDIClass I (EU MDR)
Ref B-420008Model Bonebrudge Instrument-ImModel Bonebridge Instrument-Im
Identity
- Trade Name
- Depth Gauge 3.5mm L10 - L60 EUDAMEDFDA UDI
- Generic Name
- Surgical depth gauge, reusable FDA UDI
- Device Name
- Bonebrudge Instrument-Im EUDAMEDBonebridge Instrument-Im EUDAMED
- Model / Reference
- Bonebrudge Instrument-Im EUDAMEDB-420008 EUDAMEDFDA UDIBonebridge Instrument-Im EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640187461527 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018746InstrumentsImTB EUDAMED
- Direct Marketing DI
- 07640187461527 EUDAMED
- FDA Product Code
- HTJ FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Surgical depth gauge, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4300 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
Yes
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
Depth Gauge 3.5mm L10 - L60 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 | 764018746InstrumentsImTB | 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 75bd579a-84d1-4b95-a419-f907ae18585b 61 fields · synced Jul 29, 2026
- FDA UDI 641c94bb-3027-45b6-ae15-21c8af840430 32 fields · synced May 30, 2026
- EUDAMED cc7f601d-f71f-4abf-bd23-d0d2b11cb435 61 fields · synced Jul 29, 2026