FDA.reportPublic FDA data

HiRes 90K™ Surgical Tool Kit

Primary DI
07630016809996
Brand
HiRes 90K™ Surgical Tool Kit
Company
Advanced Bionics, LLC
Model
CI-4500
Published
2015-10-08
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
P960058030

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P960058030CLARION MULTI-STRATEGY COCHLEAR IMPLANTAdvanced Bionics1997-06-26MCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630016809996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630016809996076300168099967630016809996

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
+1(661)362-1400xxx@xxx.xxx

Regulatory Flags#

DUNS number
803906382
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
07630016809606Electrode Insertion ToolMMT-61112015-10-08
07630016809927Electrode Claw ToolCI-42522015-10-14
07630016809934Recess Gauge for HiRes 90K™CI-43302015-10-08
07630016809941Coil Gauge for HiRes 90K™CI-43402015-10-08
07630016809958Helix Cochleostomy Sizing GaugeCI-43452015-10-14
07630016809965BTE-ICS Template for HiRes 90KCI-44202015-10-08
07630016809989Recess Marking Template for HiRes 90K™CI-44302015-10-08
00840094404717RF CableCI-5415-3032023-01-13
00840094404731RF CableCI-5415-3052023-01-13
00840094404748RF CableCI-5415-3012023-01-13
00840094404755RF CableCI-5415-3022023-01-13
00840094404779RF CableCI-5415-5042023-01-13
00840094404809RF CableCI-5415-5022023-01-13
00840094404878RF CableCI-5415-5042023-01-13
00840094405424UHP 3D Color CapCI-7129-3202023-01-13
00840094405431UHP 3D Color CapCI-7129-3302023-01-13
00840094405448UHP 3D Color CapCI-7129-3402023-01-13
00840094405455UHP 3D Color CapCI-7129-3502023-01-13
00840094405462UHP 3D Color CapCI-7129-3602022-12-09
00840094405479UHP 3D Color CapCI-7129-3702022-12-09

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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
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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
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