FDA.reportPublic FDA data

Cochlear ™ Nucleus® ABI541 Auditory Brainstem Implant

Primary DI
09321502020404
Brand
Cochlear ™ Nucleus® ABI541 Auditory Brainstem Implant
Company
COCHLEAR LIMITED
Model
Z246604
Catalog number
Z246604
Device description
N/A
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MHEImplant, auditory brainstem

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHEImplant, Auditory BrainstemUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P000015012

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P000015012NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEMCochlear Americas2000-10-20MHE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09321502020404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09321502020404093215020204049321502020404

GMDN Terms#

Term, Definition table
TermDefinition
Auditory brainstem implant system electrode array assemblyThe sterile implantable portion of an auditory brainstem implant system that typically consists of a battery-powered receiver-stimulator and an electrode array surgically placed on the brainstem's cochlear nucleus. The external portion of the device transmits electrical signals to the receiver-stimulator where they are decoded and sent to the multichannel electrode array to stimulate the brainstem's cochlear nucleus; this results in the signal's transmission to the brain where it is interpreted as sound.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-10 Degrees Celsius55 Degrees Celsius
Special Storage Condition, Specify00Keep Dry
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
750551194
Device count
1
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09321502053082Cochlear® Nucleus® Nexa™ cochlear implant with Slim Straight electrodeCI1022Z3342042025-07-07
09321502053099Cochlear® Nucleus® Nexa™ cochlear implant with Slim Modiolar electrodeCI1032P14349292025-07-07
09321502053105Cochlear® Nucleus® Nexa™ cochlear implant with Slim 20 electrodeCI1024P15496742025-07-07
09321502069847Cochlear® Nucleus® Nexa™ cochlear implantCI1012P19795762025-07-07
09321502014564Cochlear® Nucleus® CI512 cochlear ImplantCI512Z2090512014-09-24
09321502032599Cochlear® Nucleus® CI522 cochlear Implant with Slim Straight electrodeCI522Z3826602016-09-20
09321502032612Cochlear® Nucleus® CI532 cochlear Implant with Slim Modiolar electrodeCI532Z2856542016-09-20
09321502046329Cochlear® Nucleus® CI624 cochlear implant with Slim 20 electrodeCI624P14316762020-02-18
09321502036573Cochlear® Nucleus® CI622 cochlear Implant with Slim Straight electrodeCI622P7838292019-07-12
09321502036580Cochlear® Nucleus® CI632 cochlear Implant with Slim Modiolar electrodeCI632P7838312019-07-12
09321502036818Cochlear® Nucleus® CI612 cochlear ImplantCI612P7746002019-07-12
09321502046459CochlearP1624218P16242182020-01-03
09321502046466CochlearP1624188P16241882020-01-03
09321502046473CochlearP1624189P16241892020-01-03
09321502046480CochlearP1624190P16241902020-01-03
09321502046497CochlearP1624191P16241912020-01-03
09321502039864Nucleus® 7 Processing UnitCP1000Z5445592017-07-07
09321502063692Cochlear™ Personalisation CoverP1840531P18405312022-11-30
09321502063715Cochlear™ Personalisation CoverP1840591P18405912022-11-30
09321502066815Cochlear™ Microphone CoverP1878176P18781762022-11-29