FDA.reportPublic FDA data

Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil

Primary DI
09321502053785
Brand
Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil
Company
COCHLEAR LIMITED
Model
"Black, 8cm (3"")"
Catalog number
P1749659
Device description
Hearing Implant Accessory
Published
2025-07-07
Public version status
Update
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
P970051225

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P970051225NUCLEUS 24 COCHLEAR IMPLANT SYSTEMCochlear Americas1998-06-25MCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09321502053785PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09321502053785093215020537859321502053785

GMDN Terms#

Term, Definition table
TermDefinition
Cochlear implant/auditory brainstem implant coilAn external component of a cochlear implant (CI) or auditory brainstem implant system designed to transmit the electrical signals generated by the sound processor to the implantable receiver-stimulator and electrode array assembly (none included) of the hearing implant for the partial restoration of auditory sensation in a severely/profoundly deaf person. It is typically a round-shaped device with a magnet in its centre to magnetically couple with the implantable receiver-stimulator.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
750551194
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09321502039864Nucleus® 7 Processing UnitCP1000Z5445592017-07-07
09321502014564Cochlear® Nucleus® CI512 cochlear ImplantCI512Z2090512014-09-24
09321502063692Cochlear™ Personalisation CoverP1840531P18405312022-11-30
09321502063715Cochlear™ Personalisation CoverP1840591P18405912022-11-30
09321502066815Cochlear™ Microphone CoverP1878176P18781762022-11-29
09321502066822Cochlear™ Microphone CoverP1878194P18781942022-11-29
09321502066839Cochlear™ Microphone CoverP1878177P18781772022-11-29
09321502066846Cochlear™ Microphone CoverP1878196P18781962022-11-29
09321502066853Cochlear™ Microphone CoverP1878199P18781992022-11-29
09321502066860Cochlear™ Microphone CoverP1878197P18781972022-11-29
09321502006910NucleusZ33012Z330122014-09-24
09321502053662Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil"Black, 6cm (2 1/2"")"P17496472025-07-07
09321502053679Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil"Brown, 6cm (2 1/2"")"P17496482025-07-07
09321502053686Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil"Grey, 6cm (2 1/2"")"P17496492025-07-07
09321502053693Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil"Sand, 6cm (2 1/2"")"P17496502025-07-07
09321502053709Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil"White, 6cm (2 1/2"")"P17496512025-07-07
09321502053716Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil"Silver, 6cm (2 1/2"")"P17496522025-07-07
09321502053792Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil"Brown, 8cm (3"")"P17496602025-07-07
09321502053808Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil"Grey, 8cm (3"")"P17496612025-07-07
09321502053815Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil"Sand, 8cm (3"")"P17496622025-07-07

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