MAGNET INSERT,5M, GREY Z60421

GUDID 09321502008921

MAGNET INSERT,5M, GREY

COCHLEAR LIMITED

Hearing implant system external magnet
Primary Device ID09321502008921
NIH Device Record Key3dc31c14-10f2-47df-a172-41d8398f361e
Commercial Distribution Discontinuation2019-11-14
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMAGNET INSERT,5M, GREY
Version Model NumberZ60421
Catalog NumberZ60421
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS109321502008921 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCMIMPLANT, COCHLEAR

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

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

Devices Manufactured by COCHLEAR LIMITED

09321502009218 - Nucleus2023-11-21 Cochlear Nucleus AOS Forceps for the Contour Advance Electrode
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
09321502046138 - Cochlear2023-11-03 Osia Smart App (iOS)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.