Universal2 Total Wrist Implant System

FDA UDI

Class I (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: Universal2 Total Wrist Implant System FDA UDI
Generic Name: Surgical drill guide, reusable FDA UDI
Device Name: GUIDE PLATE. LARGE FDA UDI
Model / Reference: 268123 FDA UDI
Description: GUIDE PLATE. LARGE FDA UDI

Identifiers

Catalog Number: 268123 FDA UDI
Primary DI / UDI-DI: 00885556865354 FDA UDI
FDA Product Code: FZX FDA UDI
GMDN Term: Surgical drill guide, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical drill guide, reusable

Universal2 Total Wrist Implant System by Smith & Nephew, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · 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: Smith & Nephew, Inc.

Sources (1)

FDA UDI b520f292-92e3-4694-80ee-f1d35bc524a8 35 fields · synced Jun 8, 2026