Guidewire 0.6 Single Use

GUDID EFIAE0139131

The product GuideWire 0.6 Singel Use is a variant of a navigated probe for image guided surgical procedures with the XprESS LoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation Tool. The instrument is an accessory to the Fiagon navigation system. It is designed to be used with the Fiagon Navigation system and with XprESS LoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation Tool. The XprESS LoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation Tool are produced by Entellus Medical Inc./USA and are registered as 510K devices with the FDA. These are not subject of this instructions for use.

Fiagon GmbH

Multi-purpose stereotactic surgery system

Primary Device ID	EFIAE0139131
NIH Device Record Key	92f19be0-3e88-47fc-b31d-69350d6c03d2
Commercial Distribution Status	In Commercial Distribution
Brand Name	Guidewire 0.6 Single Use
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	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
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

Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter
Length	278 Millimeter
Outer Diameter	0.6 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EFIAE0139131 [Primary]

FDA Product Code

PGW	Ear, Nose, And Throat Stereotaxic Instrument

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-03-29
Device Publish Date	2017-11-23

Devices Manufactured by Fiagon GmbH

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