Navigation Headrest Maquet

GUDID EFIAE0110021

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.

Fiagon GmbH

Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system
Primary Device IDEFIAE0110021
NIH Device Record Keye9913027-d56d-4fff-baba-ba118c454343
Commercial Distribution StatusIn Commercial Distribution
Brand NameNavigation Headrest Maquet
Version Model Number1
Company DUNS312623008
Company NameFiagon GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com
Phone+1 336 428 2241
Emailsupport@fiagon.com

Device Dimensions

Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter
Weight10.2 Kilogram
Height120 Millimeter
Width280 Millimeter
Length580 Millimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEFIAE0110021 [Primary]

FDA Product Code

PGWEar, Nose, And Throat Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-05

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