First Choice DRUJ System

FDA UDI

Class I (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: First Choice DRUJ System FDA UDI
Generic Name: Bone cutter FDA UDI
Device Name: UH DISPOSABLE PACK FOR HALL FDA UDI
Model / Reference: UH-DIS-HAL FDA UDI
Description: UH DISPOSABLE PACK FOR HALL FDA UDI

Identifiers

Catalog Number: UH-DIS-HAL FDA UDI
Primary DI / UDI-DI: 00885556826669 FDA UDI
FDA Product Code: HAB FDA UDI
HTZ FDA UDI
GMDN Term: Bone cutter FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4820 FDA UDI
878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Bone cutter

First Choice DRUJ System by Smith & Nephew, Inc. — 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: Smith & Nephew, Inc.

Sources (1)

FDA UDI 74741475-d421-4285-9562-ae8b10524c85 35 fields · synced Jun 6, 2026