Localizer Headband

GUDID EFIAE0122001

The product Localizer Headband is a product variant of a patient reference localisator. for image guided surgical procedures.The navigation system and its accessories are intended for use by healthcare professionals only. In addition, the users receive a training. The operator, i.e., the person or facility that is responsible for the use and service of the system, must ensure that all users of the system receive an adequate introduction into the system in accordance with valid laws and regulations. An operator is everyone who uses the system. The localizer as a part of the navigation system serves as a reference fixed to the patient. The instructions for use of the navigation system describe the proper use of the entire system in detail.

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 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 ID	EFIAE0122001
NIH Device Record Key	eea92179-a8dc-4508-a51a-7337e8d5b3b6
Commercial Distribution Status	In Commercial Distribution
Brand Name	Localizer Headband
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

Device Dimensions

Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter
Weight	0.035 Kilogram
Height	15 Millimeter
Width	30 Millimeter
Length	45 Millimeter

Operating and Storage Conditions

Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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	EFIAE0122000 [Direct Marking]
HIBCC	EFIAE0122001 [Primary]

FDA Product Code

PGW	Ear, Nose, And Throat 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	3
Public Version Date	2020-03-30
Device Publish Date	2016-08-05

Devices Manufactured by Fiagon GmbH

04260759930010 - Navigation Sensor Flexarm	2024-01-15 Field generating device, component of RIWOtrack Navigation System
04260759930027 - Localizer K-Wire	2024-01-15 Patient referencing device, component of RIWOtrack Navigation System
04260759930034 - MapperBridge	2024-01-15 Patient registration device, component of RIWOtrack Navigation System
04260759930041 - MultiPad	2024-01-15 Tool registration device, component of RIWOtrack Navigation System
04260759930058 - RIWOtrack Cube4D	2024-01-15 Navigation unit, Component of RIWOtrack Navigation System
04260759930072 - Adapter for Flexsensor	2024-01-15 Adapter for navigation probe, to be used with RIWOtrack Flexsensor, component of RIWOtrack Navigation System
04260759930089 - Adapter for Clipsensor	2024-01-15 Adapter for navigation probe, to be used with RIWOtrack Clipsensor, component of RIWOtrack Navigation System
04260759930096 - RIWOtrack Flexsensor	2024-01-15 Navigation probe, component of RIWOtrack Navigation System