FDA.reportPublic FDA data

Cochlear™ Hybrid™ Receiver, 100, 4R

Primary DI
09321502038584
Brand
Cochlear™ Hybrid™ Receiver, 100, 4R
Company
COCHLEAR LIMITED
Model
Z544987
Catalog number
Z544987
Device description
N/A
Published
2017-07-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
P970051151

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P970051151NUCLEUS 24 COCHLEAR IMPLANT SYSTEMCochlear Americas1998-06-25MCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09321502038584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09321502038584093215020385849321502038584

GMDN Terms#

Term, Definition table
TermDefinition
Earphone, insertAn electroacoustic device intended to be worn in the ear to transmit sound to the ear from an external device for improved hearing or private listening. It is designed to fit either in the outer ear or is attached directly to a connecting element such as an earmould inserted in the ear canal.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
750551194
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09321502046459CochlearP1624218P16242182020-01-03
09321502046466CochlearP1624188P16241882020-01-03
09321502046473CochlearP1624189P16241892020-01-03
09321502046480CochlearP1624190P16241902020-01-03
09321502046497CochlearP1624191P16241912020-01-03
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

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