Thru Hex Driver

FDA UDI

Class I (US FDA UDI)

by Etgar - Medical Instruments Ltd

Identity

Trade Name: Thru Hex Driver FDA UDI
Generic Name: Surgical screwdriver, single-use, non-sterile FDA UDI
Device Name: DIVA - Thru Hex Driver FDA UDI
Model / Reference: 200-300-TD2.42 FDA UDI
Description: DIVA - Thru Hex Driver FDA UDI

Identifiers

Primary DI / UDI-DI: 07290112447678 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Surgical screwdriver, single-use, non-sterile FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3980 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

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

MRI Safety

MR Conditional FDA UDI

Category: Surgical screwdriver, single-use, non-sterile

Thru Hex Driver by Etgar - Medical Instruments Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Etgar - Medical Instruments Ltd

Sources (1)

FDA UDI 685071d8-07a9-42bc-8b8d-bee00e0dae41 33 fields · synced May 30, 2026