Shark Screw® driver

FDA UDI

Class I (US FDA UDI)

by surgebright GmbH

Identity

Trade Name: Shark Screw® driver FDA UDI
Generic Name: Surgical screwdriver, reusable FDA UDI
Device Name: Driver for Shark Screw® cut FDA UDI
Model / Reference: USCDRV FDA UDI
Description: Driver for Shark Screw® cut FDA UDI

Identifiers

Primary DI / UDI-DI: 09120125220228 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

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical screwdriver, reusable

Shark Screw® driver by surgebright GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 (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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: surgebright GmbH

Sources (1)

FDA UDI aeff33fc-1268-49bf-a326-174af18f6b7b 33 fields · synced Jun 6, 2026