SureTrak®

FDA UDI

Class II (US FDA UDI)

by Medtronic Navigation, Inc.

Identity

Trade Name: SureTrak® FDA UDI
Generic Name: Multi-purpose stereotactic surgery system FDA UDI
Device Name: INST KIT 9735325 SURETRAK II SM FIGHTER FDA UDI
Model / Reference: 9735325 FDA UDI
Description: INST KIT 9735325 SURETRAK II SM FIGHTER FDA UDI

Identifiers

Primary DI / UDI-DI: 00763000205966 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: Multi-purpose stereotactic surgery system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 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

Yes

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

Category: Multi-purpose stereotactic surgery system

SureTrak® 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 d5ffcc25-638f-4905-9786-8459011ff8ed 34 fields · synced Jun 6, 2026