Navigation Headrest Universal

GUDID EFIAE0110031

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

Fiagon GmbH

Multi-purpose stereotactic surgery system

Primary Device ID	EFIAE0110031
NIH Device Record Key	07a62d4c-6d3d-4d03-99d8-5ccc3176d1ee
Commercial Distribution Status	In Commercial Distribution
Brand Name	Navigation Headrest Universal
Version Model Number	1
Company DUNS	312623008
Company Name	Fiagon GmbH
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com
Phone	+13364282241
Email	support@fiagon.com

Device Dimensions

Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter
Weight	9.6 Kilogram
Height	120 Millimeter
Width	300 Millimeter
Length	550 Millimeter

Operating and Storage Conditions

Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EFIAE0110031 [Primary]

FDA Product Code

HAW	Neurological Stereotaxic Instrument

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-03-29
Device Publish Date	2016-08-05

On-Brand Devices [Navigation Headrest Universal]

EFIAE0110031	The Navigation headrest is mounted on the OR table instead of the original headrest. It comprise
04260759930256	Headrest for navigation. Navigation sensor support for image guided surgery. The device is acces