Visualase

FDA UDI

Class II (US FDA UDI)

by Medtronic Navigation, Inc.

Identity

Trade Name: Visualase FDA UDI
Generic Name: Neurological stereotactic surgery system FDA UDI
Device Name: TUBE SET 9735998 CRANIAL REDUCING FDA UDI
Model / Reference: 9735998 FDA UDI
Description: TUBE SET 9735998 CRANIAL REDUCING FDA UDI

Identifiers

Primary DI / UDI-DI: 00643169969421 FDA UDI
510(k) Number: K162604 FDA UDI
FDA Product Code: HAW FDA UDI
GMDN Term: Neurological stereotactic surgery system 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

Category: Neurological stereotactic surgery system

Visualase 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 d4f45adb-1052-44fe-af85-3bd3bc3573f4 35 fields · synced May 30, 2026