Localizer Adhesive pad

FDA UDI

Class II (US FDA UDI)

by Fiagon GmbH

Identity

Trade Name: Localizer Adhesive pad FDA UDI
Generic Name: Multi-purpose stereotactic surgery system FDA UDI
Device Name: The localizer as a part of the navigation system serves as a reference fixed to the patient. The instructions for use of the navigation system describe the proper use of the entire system in detail. The adhesive pad is an important accessory of the Localizer Adhesive pad. FDA UDI
Model / Reference: 1 FDA UDI
Description: The localizer as a part of the navigation system serves as a reference fixed to the patient. The instructions for use of the navigation system describe the proper use of the entire system in detail. The adhesive pad is an important accessory of the Localizer Adhesive pad. FDA UDI

Identifiers

Primary DI / UDI-DI: EFIAE0122021 FDA UDI
FDA Product Code: PGW FDA UDI
GMDN Term: Multi-purpose 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Weight — 0.025 Kilogram FDA UDI

Category: Multi-purpose stereotactic surgery system

Localizer Adhesive pad by Fiagon GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-purpose stereotactic surgery system.

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Mo¨ller® — MEDTRONIC NAVIGATION, INC. · Class II
StealthStation® S7® — MEDTRONIC NAVIGATION, INC. · Class II
NIM-Spine — MEDTRONIC SOFAMOR DANEK, INC. · Class II
UNIVERSAL NAVIGATION VIPER SYSTEM — MEDOS INTERNATIONAL SARL · Class IIa
NAVIGATION ENABLED INSTRUMENTS — MEDOS INTERNATIONAL SARL · Class IIa

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: Fiagon GmbH

Sources (1)

FDA UDI f073a8de-c83b-46af-98bf-6c05854e7050 36 fields · synced Jun 8, 2026