Shukla Spine-TL S9SPINE-TL, Shukla Spine-CTL S9SPINE-CTL

FDA UDI

Class I (US FDA UDI)

by Shukla Medical

Identity

Trade Name: Shukla Spine-TL S9SPINE-TL, Shukla Spine-CTL S9SPINE-CTL FDA UDI
Generic Name: Surgical screwdriver, reusable FDA UDI
Device Name: Driver Assy, Male, Hexalobe, X25 FDA UDI
Model / Reference: SDR878 FDA UDI
Description: Driver Assy, Male, Hexalobe, X25 FDA UDI

Identifiers

Primary DI / UDI-DI: B756SDR8780 FDA UDI
FDA Product Code: HXX FDA UDI
GMDN Term: Surgical screwdriver, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical screwdriver, reusable

Shukla Spine-TL S9SPINE-TL, Shukla Spine-CTL S9SPINE-CTL by Shukla Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Surgical screwdriver, reusable.

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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 (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Shukla Medical

Sources (1)

FDA UDI 949626aa-389e-4312-8cf2-4886679ff99f 34 fields · synced May 30, 2026