SONNET 2 EAS Audio Processor 40098

GUDID 09008737400989

SONNET 2 EAS Me1520 (w/o Magnet RCB) ebony

Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Cochlear implant system sound processor
Primary Device ID09008737400989
NIH Device Record Key9c14573b-d28f-40e5-99d7-b4fea2864f39
Commercial Distribution StatusIn Commercial Distribution
Brand NameSONNET 2 EAS Audio Processor
Version Model Number40098
Catalog Number40098
Company DUNS300764032
Company NameMed-El Elektromedizinische Geräte Gesellschaft m.b.H.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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

Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar

Device Identifiers

Device Issuing AgencyDevice ID
GS109008737400989 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCMImplant, Cochlear
PGQCochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-28
Device Publish Date2019-10-18

On-Brand Devices [SONNET 2 EAS Audio Processor]

09008737401085SONNET 2 EAS Me1520 (w/o Magnet BAT) nordic grey
09008737401078SONNET 2 EAS Me1520 (w/o Magnet BAT) beige
09008737401061SONNET 2 EAS Me1520 (w/o Magnet BAT) white
09008737401054SONNET 2 EAS Me1520 (w/o Magnet BAT) black
09008737401047SONNET 2 EAS Me1520 (w/o Magnet BAT) ebony
09008737401030SONNET 2 EAS Me1520 (w/o Magnet BAT) anthracite
09008737401023SONNET 2 EAS Me1520 (w/o Magnet RCB) nordic grey
09008737401016SONNET 2 EAS Me1520 (w/o Magnet RCB) beige
09008737401009SONNET 2 EAS Me1520 (w/o Magnet RCB) white
09008737400996SONNET 2 EAS Me1520 (w/o Magnet RCB) black
09008737400989SONNET 2 EAS Me1520 (w/o Magnet RCB) ebony
09008737400972SONNET 2 EAS Me1520 (w/o Magnet RCB) anthracite
09008737380045SONNET 2 EAS CPU Me1523 nordic grey PoM
09008737380038SONNET 2 EAS CPU Me1522 nordic grey PoM
09008737380021SONNET 2 EAS CPU Me1521 nordic grey PoM
09008737380014SONNET 2 EAS CPU Me1520 nordic grey PoM
09008737379964SONNET 2 EAS CPU Me1523 beige PoM
09008737379957SONNET 2 EAS CPU Me1522 beige PoM
09008737379940SONNET 2 EAS CPU Me1521 beige PoM
09008737379933SONNET 2 EAS CPU Me1520 beige PoM
09008737379889SONNET 2 EAS CPU Me1523 white PoM
09008737379872SONNET 2 EAS CPU Me1522 white PoM
09008737379865SONNET 2 EAS CPU Me1521 white PoM
09008737379858SONNET 2 EAS CPU Me1520 white PoM
09008737379803SONNET 2 EAS CPU Me1523 black PoM
09008737379797SONNET 2 EAS CPU Me1522 black PoM
09008737379780SONNET 2 EAS CPU Me1521 black PoM
09008737379773SONNET 2 EAS CPU Me1520 black PoM
09008737379728SONNET 2 EAS CPU Me1523 ebony PoM
09008737379711SONNET 2 EAS CPU Me1522 ebony PoM
09008737379704SONNET 2 EAS CPU Me1521 ebony PoM
09008737379698SONNET 2 EAS CPU Me1520 ebony PoM
09008737379643SONNET 2 EAS CPU Me1523 anthracite PoM
09008737379636SONNET 2 EAS CPU Me1522 anthracite PoM
09008737379629SONNET 2 EAS CPU Me1521 anthracite PoM
09008737379612SONNET 2 EAS CPU Me1520 anthracite PoM
09008737375676SONNET 2 EAS Me1520 (AXIAL BAT) nordic grey
09008737375645SONNET 2 EAS Me1520 (AXIAL BAT) black
09008737375607SONNET 2 EAS Me1520 (AXIAL RCB) beige
09008737375591SONNET 2 EAS Me1520 (AXIAL RCB) white
09008737375584SONNET 2 EAS Me1520 (AXIAL RCB) black
09008737375577SONNET 2 EAS Me1520 (AXIAL RCB) ebony
09008737375560SONNET 2 EAS Me1520 (AXIAL RCB) anthracite
09008737375072SONNET 2 EAS Me1520 (DIAM. BAT) nordic grey
09008737375065SONNET 2 EAS Me1520 (DIAM. BAT) beige
09008737375058SONNET 2 EAS Me1520 (DIAM. BAT) white
09008737375041SONNET 2 EAS Me1520 (DIAM. BAT) black
09008737375034SONNET 2 EAS Me1520 (DIAM. BAT) ebony
09008737375027SONNET 2 EAS Me1520 (DIAM. BAT) anthracite
09008737375010SONNET 2 EAS Me1520 (DIAM. RCB) nordic grey

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.