FDA.reportPublic FDA data

Cochlear™ Safety Line (Short Double Loop)

Primary DI
09321502036009
Brand
Cochlear™ Safety Line (Short Double Loop)
Company
COCHLEAR LIMITED
Model
P789713
Catalog number
P789713
Device description
White
Published
2016-10-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
P970051143

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P970051143NUCLEUS 24 COCHLEAR IMPLANT SYSTEMCochlear Americas1998-06-25MCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09321502036009PrimaryGS10
09321502040563Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09321502036009093215020360099321502036009
09321502040563093215020405639321502040563

GMDN Terms#

Term, Definition table
TermDefinition
Cochlear implant system sound processor earhookA small hook-shaped or formable device designed to be attached to a cochlear implant sound processor to facilitate wearing behind the ear. It is typically made of synthetic polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
750551194
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
09321502053785Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil"Black, 8cm (3"")"P17496592025-07-07
09321502053792Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil"Brown, 8cm (3"")"P17496602025-07-07
09321502053808Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil"Grey, 8cm (3"")"P17496612025-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09321502082341Cochlear™ ECochG MeasuresCOCHLEAR LIMITEDMCM2025-10-22
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09321502072243Cochlear™ Kanso® 3 Microphone CoverCOCHLEAR LIMITEDMCM2025-07-07
09321502072250Cochlear™ Kanso® 3 Microphone CoverCOCHLEAR LIMITEDMCM2025-07-07
09321502072267Cochlear™ Kanso® 3 Microphone CoverCOCHLEAR LIMITEDMCM2025-07-07
09321502072274Cochlear™ Kanso® 3 Microphone CoverCOCHLEAR LIMITEDMCM2025-07-07
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