Bronze SureTrak® II System

FDA UDI

Class II (US FDA UDI)

by Medtronic Navigation, Inc.

Identity

Trade Name: Bronze SureTrak® II System FDA UDI
Generic Name: Surgical screwdriver, reusable FDA UDI
Device Name: SCREWDRIVER 961584 SURETRAK2 FDA UDI
Model / Reference: 961584 FDA UDI
Description: SCREWDRIVER 961584 SURETRAK2 FDA UDI

Identifiers

Primary DI / UDI-DI: 00721902672316 FDA UDI
FDA Product Code: OLO FDA UDI
GMDN Term: Surgical screwdriver, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 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

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

MRI Safety

MR Conditional FDA UDI

Category: Surgical screwdriver, reusable

Bronze SureTrak® II System by Medtronic Navigation, Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Medtronic Navigation, Inc.

Sources (1)

FDA UDI 967b729a-00c6-449a-8ce7-18efe792eb9e 34 fields · synced May 30, 2026