Transform (T3 Applicator) AG609899A

GUDID 07290016633689

Transform (T3 Applicator)

INMODE M.D LTD

Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator
Primary Device ID07290016633689
NIH Device Record Keyb96b5bca-d28a-4685-81cb-f490a4533f30
Commercial Distribution StatusIn Commercial Distribution
Brand NameTransform (T3 Applicator)
Version Model NumberAG609899A
Catalog NumberAG609899A
Company DUNS600417351
Company NameINMODE M.D LTD
Device Count1
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016633689 [Primary]

FDA Product Code

GJZCyanomethemoglobin Reagent And Standard Solution
GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-04
Device Publish Date2022-10-27

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07290019863021 - Morpheus8C Handpiece2024-04-01 Morpheus8C Handpiece is intended for use in dermatologic procedures for electrocoagulation and hemostasis.
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07290019863311 - InMode OP2024-04-01 The InMode OP System is employing three different technologies for various aesthetic applications – Laser, Intense Pulsed Ligh

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