CUSTOM SOUND PRO 7.0 CD

GUDID 09321502074148

Cochlear Americas Corporation

Audiometric/hearing device software
Primary Device ID09321502074148
NIH Device Record Key5b9e9930-0b36-4729-87f6-36e4f2a4ec5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCUSTOM SOUND PRO 7.0 CD
Version Model NumberP2002452CD
Company DUNS130866817
Company NameCochlear Americas Corporation
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS109321502074148 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-11
Device Publish Date2024-01-03

Devices Manufactured by Cochlear Americas Corporation

09321502074117 - BAHA FITTING SOFTWARE 5 CD2024-01-11
09321502074124 - BAHA FITTING SOFTWARE 6 CD2024-01-11
09321502074131 - OSIA FITTING SOFTWARE 2 CD2024-01-11
09321502074148 - CUSTOM SOUND PRO 7.0 CD2024-01-11
09321502074148 - CUSTOM SOUND PRO 7.0 CD2024-01-11
09321502030434 - Field Bone-Anchored Drill Kit2023-07-04
09321502070690 - Rental Bone-Anchored Drill Kit2023-07-04

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