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T-Handle, 1/4" Square Lok
EUDAMEDFDA UDIClass I (EU MDR)
Ref NR133000-A
by Tecomet, Inc
Identity
- Trade Name
- T-Handle, 1/4" Square Lok EUDAMEDTecomet FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- Fixed Handles EUDAMEDFixed, Multi-Purpose, 1/4" Square Quick Lock, Black FDA UDI
- Model / Reference
- NR133000-A EUDAMEDFDA UDI
- Description
- Fixed, Multi-Purpose, 1/4" Square Quick Lock, Black FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841435112476 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841435147829VN EUDAMED
- Direct Marketing DI
- 00841435112476 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
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
Category: Surgical screwdriver, reusable
T-Handle, 1/4" Square Lok by Tecomet, Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 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 4beb2583-91de-44af-97b2-b1fa20bd3a34 61 fields · synced Sep 18, 2026
- FDA UDI 12e6297d-a735-43b2-b116-da032662b296 33 fields · synced May 29, 2026