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Integral
EUDAMEDFDA UDIClass I (EU MDR)
Ref GTIWG42SModel Torque transmission instrument - class Ir & Tin
by anthogyr
Identity
- Trade Name
- Integral EUDAMEDAXIOM® FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- GUIDED IMPL WRCH TL G4.2 S FDA UDI
- Model / Reference
- Torque transmission instrument - class Ir & Tin EUDAMEDGTIWG42S EUDAMEDFDA UDI
- Description
- GUIDED IMPL WRCH TL G4.2 S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03663394485029 EUDAMEDFDA UDI
- Basic UDI-DI
- 36633940135R2 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- France 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 21.2 Millimeter FDA UDIOuter Diameter — 8 Millimeter FDA UDI
Integral by anthogyr — 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 | 36633940135R2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- anthogyr
- EUDAMED SRN
- FR-MF-000000602
Sources (2)
- EUDAMED 61ea6f45-ab12-474e-b029-dfac51bc6ccd 61 fields · synced Jul 9, 2026
- FDA UDI f0dfb36a-3135-4a96-8b7a-399e4c91054a 34 fields · synced May 30, 2026