MED-EL CONCERT 07680

GUDID 09008737062750

Mi1000 MED‐EL CONCERT PIN +FLEXSOFT

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

Cochlear implant system
Primary Device ID09008737062750
NIH Device Record Key62e91345-9c0c-45fa-ac2c-eafac66fa937
Commercial Distribution StatusIn Commercial Distribution
Brand NameMED-EL CONCERT
Version Model Number06275
Catalog Number07680
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

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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS109008737062750 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCMImplant, Cochlear

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-10-19
Device Publish Date2018-04-19

On-Brand Devices [MED-EL CONCERT]

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09008737309398Mi1000 MED-EL CONCERT PIN +FLEX20
09008737062767Mi1000 MED-EL CONCERT +FLEXSOFT
09008737062750Mi1000 MED‐EL CONCERT PIN +FLEXSOFT

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