Fiagon Navigation Unit

GUDID EFIAE0111031

The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The device is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy This also comprises of accessories 1) Extension cable instrument 2) Extension Cable localizer 3) FootSwitch 4) Double Instrument support 5) PC mouse 6) Service Keyboard 7)DVI monitor cable 8) VGA monitor cable 9)Monitor cable control 10) HDMI monitor cable 11) Composite video Cable 12) Power Cable (US)

Fiagon GmbH

Multi-purpose stereotactic surgery system

Primary Device ID	EFIAE0111031
NIH Device Record Key	99c2ef58-de68-42a9-ab7e-79cf6317349d
Commercial Distribution Status	In Commercial Distribution
Brand Name	Fiagon Navigation Unit
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

Device Dimensions

Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter
Height	135 Millimeter
Width	315 Millimeter
Weight	11.7 Kilogram
Length	365 Millimeter

Operating and Storage Conditions

Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Protected aginst dust and moisture
Handling Environment Temperature	Between 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EFIAE0111030 [Direct Marking]
HIBCC	EFIAE0111031 [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	2020-05-13
Device Publish Date	2016-08-05

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