Identity
- Trade Name
- Quick-Start FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Quick-Start Screwdriver 3.5mm Hex EUDAMEDQuick-Start Screwdriver 3.5mm Hex, 2.0mm Cannulation FDA UDI
- Model / Reference
- 10026 EUDAMEDFDA UDI
- Description
- Quick-Start Screwdriver 3.5mm Hex, 2.0mm Cannulation FDA UDI
Identifiers
- Catalog Number
- 10026 FDA UDI
- Primary DI / UDI-DI
- 05060464140266 EUDAMEDFDA UDI
- Basic UDI-DI
- 506046414QS-ScrewdriverFM EUDAMEDB-05060464140266 EUDAMED
- Direct Marketing DI
- 05060464140266 EUDAMED
- FDA Product Code
- HXX FDA UDI
- EMDN Code
- L26 SURGICAL SCREWDRIVERS, REUSABLE EUDAMED
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Northern Ireland 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
Quick-Start Screwdriver 3.5mm Hex by Innovate Orthopaedics — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical screwdriver, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 506046414QS-ScrewdriverFM | Class I | Active |
| EUDAMED | European Union | CE/MDR | 506046414QS-ScrewdriverFM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Innovate Orthopaedics
- EUDAMED SRN
- GB-MF-000012886
- Authorised Representative
- Acorn Regulatory Consultancy Services Ltd IE-AR-000000592
Sources (3)
- EUDAMED 0bc7b436-0df1-4f5d-aea4-b0c1d0aa22fb 61 fields · synced Aug 2, 2026
- EUDAMED f5c527b8-2fb0-4fff-8101-50123a66872a 61 fields · synced May 18, 2026
- FDA UDI d9c9f64f-16e5-494b-9c18-612e30e6c520 36 fields · synced May 30, 2026