Identity
- Trade Name
- Headless Screw System Instruments FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- Reusable Instrumentation EUDAMEDT30 (Ø2.8) Torx Driver (ZH) FDA UDI
- Model / Reference
- T001000081 EUDAMEDFDA UDI
- Description
- T30 (Ø2.8) Torx Driver (ZH) FDA UDI
Identifiers
- Catalog Number
- T001000081 FDA UDI
- Primary DI / UDI-DI
- 00810030824886 EUDAMEDFDA UDI
- Basic UDI-DI
- 081991702011AS EUDAMED
- FDA Product Code
- LXH 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
- Germany 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical screwdriver, reusable
Reusable Instrumentation by Tyber Medical — 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 | 081991702011AS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Tyber Medical
- EUDAMED SRN
- US-MF-000011350
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED ad62cd95-eb5a-4db2-a220-219fb93e280c 61 fields · synced Jul 26, 2026
- FDA UDI 311c0815-8cab-46ae-9ae9-f7061bfcc12e 35 fields · synced May 30, 2026