Adhesive Pad E 00 3001

GUDID EFIAE0030010

Intersect ENT GmbH

Multi-purpose stereotactic surgery system
Primary Device IDEFIAE0030010
NIH Device Record Key35e43553-be83-4f3f-812c-aec5f0be13b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdhesive Pad
Version Model Number1
Catalog NumberE 00 3001
Company DUNS312623008
Company NameIntersect ENT GmbH
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com
Phone+13364282241
Emailsupport@fiagon.com

Device Dimensions

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Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104260759931512 [Secondary]
HIBCCEFIAE0030010 [Unit of Use]
HIBCCEFIAE0030011 [Primary]

FDA Product Code

PGWEar, Nose, And Throat Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-31
Device Publish Date2022-01-21

Devices Manufactured by Intersect ENT GmbH

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