Driver Assy, Female, Hex, 10 mm (S9SPINE-CTL - Shukla Spine/ Universal Spinal S…
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Driver Assy, Female, Hex, 10 mm (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System) EUDAMEDShukla Spine-TL S9SPINE-TL, Shukla Spine-CTL S9SPINE-CTL FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Driver Assy, Male, Hex, 2 mm EUDAMEDDriver Assy, Female, Hex, 10 mm FDA UDI
- Model / Reference
- SDR701 EUDAMEDSDR733 EUDAMEDFDA UDI
- Description
- Driver Assy, Female, Hex, 10 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- B756SDR7330 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B756S9SPINECTLSSK3 EUDAMED
- Direct Marketing DI
- B756SDR7330 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
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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Surgical screwdriver, reusable
Driver Assy, Female, Hex, 10 mm (S9SPINE-CTL - Shukla Spine/ Universal Spinal S… by S. S. White Technologies Inc/DBA Shukla Medical — Class I — MDR, FDA UDI…
Similar devices
Also classified as Surgical screwdriver, reusable.
- Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II
- MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD. · Class I
- Inclusive — PRISMATIK DENTALCRAFT, INC. · Class I
- LOSPA IS Spinal Fixation System — Corentec Co., Ltd · Class II
- PERLA ® TL — Spineart · Class II
- USS — Synthes · Class I
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
- CosmoLock Pedicle Screw System — Kalitec Direct LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B756S9SPINECTLSSK3 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- S. S. White Technologies Inc/DBA Shukla Medical
- EUDAMED SRN
- US-MF-000007058
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 61a8e6a4-f461-4df0-971a-edd7617717e4 61 fields · synced Jun 18, 2026
- FDA UDI ad432791-1230-4bdf-b10e-fa534f8e92bc 34 fields · synced May 30, 2026