Identity
- Trade Name
- IBS™ EUDAMEDFDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- I.B.S®-C Compression and I.B.S®-N Neutralization osteosynthesis Instruments EUDAMED2IN1 DRILL DIAM 1.6 LG26 MM AO NO STERILE CANNULATED LG65 MM FDA UDI
- Model / Reference
- G01 01362 EUDAMEDFDA UDI
- Description
- 2IN1 DRILL DIAM 1.6 LG26 MM AO NO STERILE CANNULATED LG65 MM FDA UDI
Identifiers
- Catalog Number
- G01 01362 FDA UDI
- Primary DI / UDI-DI
- 03760225714492 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760225714492 EUDAMED
- FDA Product Code
- GFG FDA UDI
- EMDN Code
- L091002 INSTRUMENTS FOR PROCESSING 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
- 878.4820 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Ibs™ by In2Bones SAS — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03760225714492 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- In2Bones SAS
- EUDAMED SRN
- FR-MF-000005246
Sources (3)
- EUDAMED 9bad975c-f1b4-4c82-9228-9c82a91561e6 61 fields · synced Jun 19, 2026
- FDA UDI 41d82d78-6e6d-498b-b1af-0235945fcb97 35 fields · synced May 30, 2026
- EUDAMED ec199628-9d63-4512-b793-2f784858c8d9 61 fields · synced Jun 19, 2026