FDA.reportPublic FDA data

HiRes™ Ultra 3D CI HiFocus™ SlimJ Electrode

Primary DI
07630016878008
Brand
HiRes™ Ultra 3D CI HiFocus™ SlimJ Electrode
Company
Advanced Bionics AG
Model
CI-1601-05
Published
2020-01-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
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
P960058144

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P960058144CLARION MULTI-STRATEGY COCHLEAR IMPLANTAdvanced Bionics1997-06-26MCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630016878008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630016878008076300168780087630016878008

GMDN Terms#

Term, Definition table
TermDefinition
Cochlear implant system electrode array assemblyThe sterile implantable portion of a cochlear implant system [cochlear implant (CI)] that typically consists of a battery-powered electrode array surgically implanted in one cochlea, and a receiver-stimulator implanted in the skull near the ear and connected to the electrode array. Electrical signals are transmitted from the external portion of the device to the receiver-stimulator and ultimately to the cochlea, via the electrode array, for the partial restoration of auditory sensation in a profoundly deaf person. Dedicated implantation instruments may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal150 KiloPascal
Handling Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(661)362-1400xxx@xxx.xxx

Regulatory Flags#

DUNS number
485262658
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
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

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