MED-EL CONCERT 30970

GUDID 09008737309404

Mi1000 MED-EL CONCERT +FLEX20

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

Cochlear implant system
Primary Device ID09008737309404
NIH Device Record Key10f564ae-e7f5-4c64-856e-0f7f1b9d9faa
Commercial Distribution StatusIn Commercial Distribution
Brand NameMED-EL CONCERT
Version Model Number30940
Catalog Number30970
Company DUNS300764032
Company NameMed-El Elektromedizinische Geräte Gesellschaft m.b.H.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS109008737309404 [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 Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-10-19
Device Publish Date2016-11-07

On-Brand Devices [MED-EL CONCERT]

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09008737309398Mi1000 MED-EL CONCERT PIN +FLEX20
09008737062767Mi1000 MED-EL CONCERT +FLEXSOFT
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