Integrated Headrest

FDA UDI

Class II (US FDA UDI)

by Fiagon GmbH

Identity

Trade Name: Integrated Headrest FDA UDI
Generic Name: Multi-purpose stereotactic surgery system FDA UDI
Device Name: The Integrated Headrest is mounted on the procedure chairs. It comprises a holder for a Navigation sensor, which creates an electromagnetic field above the cushion of the Integrated Headrest. The Integrated Headrest comes with the following adapters: 1) Chair Adapter 4020 2) Chair Adapter 2512. FDA UDI
Model / Reference: E011970 FDA UDI
Description: The Integrated Headrest is mounted on the procedure chairs. It comprises a holder for a Navigation sensor, which creates an electromagnetic field above the cushion of the Integrated Headrest. The Integrated Headrest comes with the following adapters: 1) Chair Adapter 4020 2) Chair Adapter 2512. FDA UDI

Identifiers

Primary DI / UDI-DI: 04260759930003 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Multi-purpose stereotactic surgery system

Integrated Headrest by Fiagon GmbH — 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: Fiagon GmbH

Sources (1)

FDA UDI 7a8e8bd4-fd59-4895-814a-71e03068c1e3 34 fields · synced Jun 6, 2026