OPUS 2

GUDID 09008737074647

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

Cochlear implant system
Primary Device ID09008737074647
NIH Device Record Key8ff445b1-1d18-4dd7-8937-74bbfa0bdc1e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPUS 2
Version Model NumberOPUS 2 DaCapo ExtKit baby pink
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
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+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar

Device Identifiers

Device Issuing AgencyDevice ID
GS109008737074647 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCMIMPLANT, COCHLEAR

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-10-19
Device Publish Date2014-12-03

On-Brand Devices [OPUS 2]

09008737363871OPUS 2 Control Unit blue, Service Pool (SP)
09008737363864OPUS 2 Control Unit ebony, Service Pool (SP)
09008737363857OPUS 2 Control Unit white, Service Pool (SP)
09008737363840OPUS 2 Control Unit grey, Service Pool (SP)
09008737363833OPUS 2 Control Unit beige, Service Pool (SP)
09008737363826OPUS 2 Control Unit anthracite, Service Pool (SP)
09008737092672OPUS 2XS UpgrKit baby pink
09008737092665OPUS 2XS UpgrKit baby blue
09008737092658OPUS 2XS UpgrKit green
09008737092641OPUS 2XS UpgrKit orange
09008737092634OPUS 2XS UpgrKit creme
09008737092627OPUS 2XS UpgrKit ebony
09008737092610OPUS 2XS UpgrKit white
09008737092603OPUS 2XS UpgrKit brown
09008737092597OPUS 2XS UpgrKit red
09008737092580OPUS 2XS UpgrKit blue
09008737092573OPUS 2XS UpgrKit grey
09008737092566OPUS 2XS UpgrKit beige
09008737092559OPUS 2XS UpgrKit anthracite
09008737092542OPUS 2XS ExtKit baby pink
09008737092535OPUS 2XS ExtKit baby blue
09008737092528OPUS 2XS ExtKit green
09008737092511OPUS 2XS ExtKit orange
09008737092504OPUS 2XS ExtKit creme
09008737092498OPUS 2XS ExtKit ebony
09008737092481OPUS 2XS ExtKit white
09008737092474OPUS 2XS ExtKit brown
09008737092467OPUS 2XS ExtKit red
09008737092450OPUS 2XS ExtKit blue
09008737092443OPUS 2XS ExtKit grey
09008737092436OPUS 2XS ExtKit beige
09008737092429OPUS 2XS ExtKit anthracite
09008737089542OPUS 2 BP ExtKit US babypink
09008737089535OPUS 2 BP ExtKit US babyblue
09008737089528OPUS 2 BP ExtKit US green
09008737089511OPUS 2 BP ExtKit US orange
09008737089504OPUS 2 BP ExtKit US creme
09008737089498OPUS 2 BP ExtKit US ebony
09008737089481OPUS 2 BP ExtKit US white
09008737076115OPUS 2 D Coil Baby Kit b-pink
09008737076108OPUS 2 D Coil Baby Kit b-blue
09008737076092OPUS 2 D Coil Baby Kit green
09008737076085OPUS 2 D Coil Baby Kit orange
09008737076078OPUS 2 D Coil Baby Kit creme
09008737076061OPUS 2 D Coil Baby Kit ebony
09008737076054OPUS 2 D Coil Baby Kit white
09008737076047OPUS 2 D Coil Baby Kit brown
09008737076030OPUS 2 D Coil Baby Kit grey
09008737076023OPUS 2 D Coil Baby Kit blue
09008737076016OPUS 2 D Coil Baby Kit red

Trademark Results [OPUS 2]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OPUS 2
OPUS 2
98001116 not registered Live/Pending
Opus 2 Magnum Holdings Limited
2023-05-17
OPUS 2
OPUS 2
86596607 4962679 Live/Registered
Opus 2 Magnum Holdings Limited
2015-04-14
OPUS 2
OPUS 2
77012921 3516933 Live/Registered
Med-El Elektromedizinische Geräte Ges.m.b.H.
2006-10-03
OPUS 2
OPUS 2
75885240 not registered Dead/Abandoned
OPUS 2 DIRECT.COM INC.
2000-01-07
OPUS 2
OPUS 2
73127266 1096663 Dead/Cancelled
A. Schid A.G.
1977-05-19

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