Insertion Test Device

GUDID 09008737020811

INSERTION TEST DEVICE for assessment of the accessibility of the cochlea

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

Cochlear implant system
Primary Device ID09008737020811
NIH Device Record Key8a094fb4-7fda-45b0-af26-3d5dd28e7be5
Commercial Distribution StatusIn Commercial Distribution
Brand NameInsertion Test Device
Version Model Number02081
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

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
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

Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at room temperautre until the stated expiry date.

Device Identifiers

Device Issuing AgencyDevice ID
GS109008737020811 [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 Number4
Public Version Date2021-08-31
Device Publish Date2014-09-22

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

09008737383015 - SONNET 3 BabyWear Kit (DL) White2025-03-07 Audio Processor Accessory
09008737383022 - SONNET 3 BabyWear Kit (DL) Beige2025-03-07 Audio Processor Accessory
09008737383039 - SONNET 3 BabyWear Kit (DL) Nordic Gray2025-03-07 Audio Processor Accessory
09008737385842 - SONNET 3 BabyWear Kit (DL) Black2025-03-07 Audio Processor Accessory
09008737412180 - FineTuner Echo2025-03-06 Audio Processor Remote Control
09008737413415 - AudioKey 32025-03-06 Mobile application (iOS)
09008737413422 - AudioKey 32025-03-06 Mobile application (Android)
09008737434830 - SONNET 3 Kit (Me1710) BAT FTE Anthracite2025-03-06 Audio Processor Kit

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.