Navigation Headrest Universal

FDA UDI

Class II (US FDA UDI)

by Fiagon GmbH

Identity

Trade Name: Navigation Headrest Universal FDA UDI
Generic Name: Multi-purpose stereotactic surgery system FDA UDI
Device Name: The Navigation headrest is mounted on the OR table instead of the original headrest. It comprises of a sensor, which creates an electromagnetic field above the cushion of the Navigation headrest. The navigation headrest Universal comes with the following adapters: 1) Adapters for siderails 2)Adapters for Mizuho/Skytron Tables 3)Adapters for Maquet Tables 4)Adapters for Steris table 5)Adapters for Eschmann Tables 6)Flexarm adapters for for navigation sensor FDA UDI
Model / Reference: 1 FDA UDI
Description: The Navigation headrest is mounted on the OR table instead of the original headrest. It comprises of a sensor, which creates an electromagnetic field above the cushion of the Navigation headrest. The navigation headrest Universal comes with the following adapters: 1) Adapters for siderails 2)Adapters for Mizuho/Skytron Tables 3)Adapters for Maquet Tables 4)Adapters for Steris table 5)Adapters for Eschmann Tables 6)Flexarm adapters for for navigation sensor FDA UDI

Identifiers

Primary DI / UDI-DI: EFIAE0110031 FDA UDI
FDA Product Code: HAW FDA UDI
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: Not 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 — 9.6 Kilogram FDA UDI
Height — 120 Millimeter FDA UDI
Width — 300 Millimeter FDA UDI
Length — 550 Millimeter FDA UDI

Navigation Headrest Universal by Fiagon GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Fiagon GmbH

Sources (1)

FDA UDI 07a62d4c-6d3d-4d03-99d8-5ccc3176d1ee 37 fields · synced May 30, 2026