FDA.reportPublic FDA data

CUSTOM SOUND PRO 7.0 CD

Primary DI
09321502074148
Brand
CUSTOM SOUND PRO 7.0 CD
Company
Cochlear Americas Corporation
Model
P2002452CD
Published
2024-01-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MCMImplant, cochlear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCMImplant, CochlearUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P970051193

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P970051193NUCLEUS 24 COCHLEAR IMPLANT SYSTEMCochlear Americas1998-06-25MCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09321502074148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09321502074148093215020741489321502074148

GMDN Terms#

Term, Definition table
TermDefinition
Audiometric/hearing device softwareA software program intended to assist with the evaluation of a patient’s hearing capability and/or evaluate and adjust the settings of a hearing assistive device. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and intended to be used on a non-medical computerized device (e.g., smartphone, tablet).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)523-5798customer@cochlear.com

Regulatory Flags#

DUNS number
130866817
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09321502074117BAHA FITTING SOFTWARE 5 CDP803255CD2024-01-03
09321502074124BAHA FITTING SOFTWARE 6 CDP1682914CD2024-01-03
09321502074131OSIA FITTING SOFTWARE 2 CDP1348428CD2024-01-03
09321502030434Field Bone-Anchored Drill Kit91053R91053R2023-06-26
09321502070690Rental Bone-Anchored Drill KitFUZ180FUZ1802023-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09321502082341Cochlear™ ECochG MeasuresCOCHLEAR LIMITEDMCM2025-10-22
09321502072236Cochlear™ Kanso® 3 Microphone CoverCOCHLEAR LIMITEDMCM2025-07-07
09321502072243Cochlear™ Kanso® 3 Microphone CoverCOCHLEAR LIMITEDMCM2025-07-07
09321502072250Cochlear™ Kanso® 3 Microphone CoverCOCHLEAR LIMITEDMCM2025-07-07
09321502072267Cochlear™ Kanso® 3 Microphone CoverCOCHLEAR LIMITEDMCM2025-07-07
09321502072274Cochlear™ Kanso® 3 Microphone CoverCOCHLEAR LIMITEDMCM2025-07-07
00197420012543Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012567Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012581Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012604Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012628Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012642Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012666Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012680Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012703Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012727Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012741Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012765Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012789Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012802Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012826Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012840Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012864Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012888Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012901Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012925Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012949Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012963Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012987Naida™ CI M90Advanced Bionics CorporationMCM2024-12-16
00197420013007Naida™ CI M90Advanced Bionics CorporationMCM2024-12-16