Identity
- Trade Name
- TRIWAY EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- PERCUTANEOUS BURRS EUDAMEDT25 SCREWDRIVER TIP CANNULATED KWIRE 2.0 MM HUDSON FDA UDI
- Model / Reference
- G01 01591 EUDAMEDFDA UDI
- Description
- T25 SCREWDRIVER TIP CANNULATED KWIRE 2.0 MM HUDSON FDA UDI
Identifiers
- Catalog Number
- G01 01591 FDA UDI
- Primary DI / UDI-DI
- 03760225718254 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760225718254 EUDAMED
- FDA Product Code
- HXX FDA UDI
- EMDN Code
- L091002 INSTRUMENTS FOR PROCESSING MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Wire holding/twisting forceps
The TRIWAY device is a durable, percutaneous burrs system designed for use in medical procedures. It features high-quality needles and precise control over the injection process.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03760225718254 | 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 (2)
- EUDAMED a65b7af8-1294-4c61-8a67-ad7fdfd15d4f 61 fields · synced Jul 12, 2026
- FDA UDI 1741b086-91ce-48ff-bd70-b0be8fe44725 35 fields · synced May 30, 2026