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Navigation Headrest Trumpf

FDA UDI

Class II (US FDA UDI)

by Fiagon GmbH

Identity

Trade Name
Navigation Headrest Trumpf 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. 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. FDA UDI

Identifiers

Primary DI / UDI-DI
EFIAE0110091 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Weight — 9.3 Kilogram FDA UDI
Height — 160 Millimeter FDA UDI
Width — 260 Millimeter FDA UDI
Length — 500 Millimeter FDA UDI

Navigation Headrest Trumpf 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

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Manufacturer

Manufacturer
Fiagon GmbH

Sources (1)

  • FDA UDI 5adf73f9-26fb-42cc-85f4-a12aaa7d88af 37 fields · synced Jun 8, 2026