Identity
- Trade Name
- IBS™ EUDAMEDFDA UDI
- Generic Name
- Cannulated surgical drill bit, single-use FDA UDI
- Device Name
- I.B.S®-C Compression and I.B.S®-N Neutralization osteosynthesis Instruments EUDAMED2IN1 DRILL DIAM 1.6 LG18 MM AO STERILE CANULATED LG65 MM FDA UDI
- Model / Reference
- G01 01351 EUDAMEDFDA UDI
- Description
- 2IN1 DRILL DIAM 1.6 LG18 MM AO STERILE CANULATED LG65 MM FDA UDI
Identifiers
- Catalog Number
- G01 01351 FDA UDI
- Primary DI / UDI-DI
- 03760225713037 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760225713037 EUDAMED
- FDA Product Code
- GFG FDA UDI
- EMDN Code
- P091303 ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE EUDAMED
- GMDN Term
- Cannulated surgical drill bit, single-use 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
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
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-03760225713037 | 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 3265f43a-39b9-48b6-9794-d15718d7df47 61 fields · synced Jun 18, 2026
- FDA UDI d0f3ef45-186f-4210-9fcc-d6fd03431cef 35 fields · synced May 30, 2026
- EUDAMED e0e6517a-2584-4273-bd69-71841c2f89fb 61 fields · synced Jun 18, 2026