04143

GUDID 09008737041434

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

Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Hearing implant implantable-component tester, postoperative Hearing implant implantable-component tester, postoperative Hearing implant implantable-component tester, postoperative Hearing implant implantable-component tester, postoperative Hearing implant implantable-component tester, postoperative Hearing implant implantable-component tester, postoperative Hearing implant implantable-component tester, postoperative
Primary Device ID09008737041434
NIH Device Record Key8923d030-c08e-4adb-8fc9-358aab62328a
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberDIB II Coil
Catalog Number04143
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

Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
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Phone+1(888)633-3524
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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
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Phone+1(888)633-3524
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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
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Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
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Phone+1(888)633-3524
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Phone+1(888)633-3524
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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
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Phone+1(888)633-3524
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Phone+1(888)633-3524
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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

Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS109008737041434 [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 Number4
Public Version Date2021-01-27
Device Publish Date2014-09-22

Devices Manufactured by Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

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