Insertion Electrode FLEXsoft 08255

GUDID 09008737082550

Insertion Electrode FLEXSOFT

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

Cochlear implant system
Primary Device ID09008737082550
NIH Device Record Key71a6b2c5-fce0-45e2-af5b-86aa1616dbfc
Commercial Distribution StatusIn Commercial Distribution
Brand NameInsertion Electrode FLEXsoft
Version Model Number08255
Catalog Number08255
Company DUNS300764032
Company NameMed-El Elektromedizinische Geräte Gesellschaft m.b.H.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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
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 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.

Device Identifiers

Device Issuing AgencyDevice ID
GS109008737082550 [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 Date2021-08-31
Device Publish Date2018-04-19

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