Kanso Halo Accessory P1893411

GUDID 09321502066600

COCHLEAR LIMITED

Cochlear implant/auditory brainstem implant sound processor off-ear holder
Primary Device ID09321502066600
NIH Device Record Key0be6a5c3-f24c-4ae5-bf04-f6901418f371
Commercial Distribution StatusIn Commercial Distribution
Brand NameKanso Halo Accessory
Version Model NumberP1893411
Catalog NumberP1893411
Company DUNS750551194
Company NameCOCHLEAR LIMITED
Device Count2
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 Datetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS109321502065320 [Primary]
GS109321502066600 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCMImplant, cochlear

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-18
Device Publish Date2022-04-08

Devices Manufactured by COCHLEAR LIMITED

09321502014557 - Cochlear Surgical Instrument Upgrade Kit2024-11-15
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

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