CI24RE Series Sterile Replacement Magnet Z50101

GUDID 09321502002783

COCHLEAR LIMITED

Hearing implant system external magnet
Primary Device ID09321502002783
NIH Device Record Keyf4ecbd4d-331f-4a5d-b23c-86eaf236491d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCI24RE Series Sterile Replacement Magnet
Version Model NumberZ50101
Catalog NumberZ50101
Company DUNS750551194
Company NameCOCHLEAR LIMITED
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS109321502002783 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCMIMPLANT, COCHLEAR

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[09321502002783]

Ethylene Oxide


[09321502002783]

Ethylene Oxide


[09321502002783]

Ethylene Oxide


[09321502002783]

Ethylene Oxide


[09321502002783]

Ethylene Oxide


[09321502002783]

Ethylene Oxide


[09321502002783]

Ethylene Oxide


[09321502002783]

Ethylene Oxide


[09321502002783]

Ethylene Oxide


[09321502002783]

Ethylene Oxide


[09321502002783]

Ethylene Oxide


[09321502002783]

Ethylene Oxide


[09321502002783]

Ethylene Oxide


[09321502002783]

Ethylene Oxide


[09321502002783]

Ethylene Oxide


[09321502002783]

Ethylene Oxide


[09321502002783]

Ethylene Oxide


[09321502002783]

Ethylene Oxide


[09321502002783]

Ethylene Oxide


[09321502002783]

Ethylene Oxide


[09321502002783]

Ethylene Oxide


[09321502002783]

Ethylene Oxide


[09321502002783]

Ethylene Oxide


[09321502002783]

Ethylene Oxide


[09321502002783]

Ethylene Oxide


[09321502002783]

Ethylene Oxide


[09321502002783]

Ethylene Oxide


[09321502002783]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-07-28
Device Publish Date2014-09-24

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09321502036788 - Nucleus2023-11-03 Nucleus Smart App, (iOS)
09321502043205 - Nucleus2023-11-03 Custom Sound Suite 5.1 CD
09321502043212 - Nucleus2023-11-03 Custom Sound Suite 5.1 Download
09321502043236 - Nucleus2023-11-03 Nucleus Smart App
09321502044899 - Cochlear2023-11-03 Osia™ Fitting Software 2
09321502044905 - Cochlear2023-11-03 Osia™ Fitting Software 2

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