FDA.reportPublic FDA data

HiFocus™ Mid-Scala Electrode Instrument Kit

Primary DI
07630016850554
Brand
HiFocus™ Mid-Scala Electrode Instrument Kit
Company
Advanced Bionics AG
Model
CI-4508
Published
2017-01-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
P960058109

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P960058109CLARION MULTI-STRATEGY COCHLEAR IMPLANTAdvanced Bionics1997-06-26MCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630016850554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630016850554076300168505547630016850554

GMDN Terms#

Term, Definition table
TermDefinition
Cochlear implant systemA battery-powered assembly of devices [cochlear implant (CI)] intended for the partial restoration of auditory sensation to a profoundly deaf person. It consists of an inner electrode array implanted in one cochlea and connected to a receiver-stimulator implanted near the ear; and an externally worn microphone-sound processor, battery pack, coil cable, and coil (transmitter). Sound waves are converted into electrical signals by the sound processor (transducer) and sent to the coil (transmitter) via the coil cable. The coil transmits the signals to the receiver-stimulator and ultimately to the cochlea via the electrode array. Dedicated implantation instruments may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(661)362-1400xxx@xxx.xxx

Regulatory Flags#

DUNS number
485262658
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630016880575Slim HP Color Cap CI-7131-0012021-02-08
07630016880582Slim HP Color Cap CI-7131-0022021-02-08
07630016880599Slim HP Color Cap CI-7131-0032021-02-11
07630016880605Slim HP Color Cap CI-7131-0042021-02-11
07630016880612Slim HP Color Cap CI-7131-0052021-02-11
07630016880629Slim HP Color Cap CI-7131-0062021-02-11
07630016880636Slim HP Color Cap CI-7131-0072021-02-11
07630016880650Slim HP Color Cap CI-7131-0092021-02-11
07630016880667Slim HP Color Cap CI-7131-0102021-02-11
07630016880674Slim HP Color Cap CI-7132-0012021-02-11
07630016880681Slim HP Color Cap CI-7132-0022021-02-12
07630016880698Slim HP Color Cap CI-7132-0032021-02-12
07630016880704Slim HP Color Cap CI-7132-0042021-02-12
07630016880919Slim HP Color Cap CI-7131-0112021-02-11
07630016881718Slim HP Color Cap CI-7132-0052021-02-12
07630016871801UHP 3DCI-53162019-08-05
07630016871825AquaMic™3D CI-53172019-08-15
07630016873959UHP 3D PlusCI-53182019-08-07
07630016878404AB Remote CI-6058-0012021-02-12
07630016880186Slim HP AquaMic™CI-5321-0092021-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09008737461379SONNET Battery Pack Cover Standard Pro, AnthraciteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461386SONNET Battery Pack Cover Standard Pro, EbonyMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461393SONNET Battery Pack Cover Standard Pro, Nordic GrayMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461409SONNET Battery Pack Cover Standard Pro, BeigeMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461416SONNET Battery Pack Cover Standard Pro, WhiteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461423SONNET Battery Pack Cover Standard Pro, BlackMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461485SONNET Battery Pack Cover Micro Pro, AnthraciteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461492SONNET Battery Pack Cover Micro Pro, EbonyMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461508SONNET Battery Pack Cover Micro Pro, Nordic GrayMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461515SONNET Battery Pack Cover Micro Pro, BeigeMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461522SONNET Battery Pack Cover Micro Pro, WhiteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461539SONNET Battery Pack Cover Micro Pro, BlackMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
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
09321502053082Cochlear® Nucleus® Nexa™ cochlear implant with Slim Straight electrodeCOCHLEAR LIMITEDMCM2025-07-07
09321502053099Cochlear® Nucleus® Nexa™ cochlear implant with Slim Modiolar electrodeCOCHLEAR LIMITEDMCM2025-07-07
09321502053105Cochlear® Nucleus® Nexa™ cochlear implant with Slim 20 electrodeCOCHLEAR LIMITEDMCM2025-07-07
09321502069847Cochlear® Nucleus® Nexa™ cochlear implantCOCHLEAR 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