Ratcheting T-Driver, 1/4" Square, Black (1/4" Square Tru-Control™ Ratchet)
EUDAMEDFDA UDIClass I (EU MDR)
by Tecomet, Inc
Identity
- Trade Name
- Ratcheting T-Driver, 1/4" Square, Black (1/4" Square Tru-Control™ Ratchet) EUDAMEDTecomet FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- Fixed Handles EUDAMEDRatcheting Tru Control™, Comfort-T, 1/4 Square Tru Control™ Cannulated Ortho-Grip™, Black FDA UDI
- Model / Reference
- TR423000-A EUDAMEDFDA UDI
- Description
- Ratcheting Tru Control™, Comfort-T, 1/4 Square Tru Control™ Cannulated Ortho-Grip™, Black FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841435110632 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841435147829VN EUDAMED
- Direct Marketing DI
- 00841435110632 EUDAMED
- FDA Product Code
- HXX FDA UDI
- EMDN Code
- L26 SURGICAL SCREWDRIVERS, REUSABLE EUDAMED
- GMDN Term
- Surgical instrument handle, non-torque-limiting FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA 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
Yes
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
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Surgical screwdriver, reusable
Ratcheting T-Driver, 1/4" Square, Black (1/4" Square Tru-Control™ Ratchet) by Tecomet, Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0841435147829VN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Tecomet, Inc
- EUDAMED SRN
- US-MF-000027544
- Authorised Representative
- Meditec Source GmbH & Co. KG DE-AR-000009318
Sources (2)
- EUDAMED 9fde5b0a-6440-4c14-a26e-a7d4c5074b11 61 fields · synced Sep 18, 2026
- FDA UDI e4772a62-3fd3-44d3-8a0e-bbe2ead9c84a 33 fields · synced May 26, 2026