Identity
- Trade Name
- IBS™ EUDAMEDFDA UDI
- Generic Name
- Surgical depth gauge, reusable FDA UDI
- Device Name
- Instruments, orthopaedic surgeries of the upper and lower extremities EUDAMED200 MM KWIRE MEASURER DIAM 2.0/2.5 MM FDA UDI
- Model / Reference
- G01 00181 EUDAMEDFDA UDI
- Description
- 200 MM KWIRE MEASURER DIAM 2.0/2.5 MM FDA UDI
Identifiers
- Catalog Number
- G01 00181 FDA UDI
- Primary DI / UDI-DI
- 03760225713143 EUDAMEDFDA UDI
- Basic UDI-DI
- 3701337641026R EUDAMED
- FDA Product Code
- FTY FDA UDI
- EMDN Code
- L0923 ORTHOPAEDICS SURGICAL MEASURERS, REUSABLE EUDAMED
- GMDN Term
- Surgical depth gauge, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
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
No
FDA UDI
Lot / Batch Number
Yes
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 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 | 3701337641026R | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- In2Bones SAS
- EUDAMED SRN
- FR-MF-000005246
Sources (3)
- EUDAMED 6a7aadc6-1b6c-4e1a-b19a-234e740d715f 61 fields · synced Jun 19, 2026
- FDA UDI c007dcd3-f0a6-4250-a1e3-20b6bfbe511a 35 fields · synced May 29, 2026
- EUDAMED f6a1fa01-3873-4c2f-942d-1cc42bb25fbb 61 fields · synced Jun 19, 2026