FDA.reportPublic FDA data

Cochlear

Primary DI
09321502045063
Brand
Cochlear
Company
COCHLEAR LIMITED
Model
P1233400
Catalog number
P1233400
Device description
Osia 2 Sound Processor Kit
Published
2019-11-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PFOActive implantable bone conduction hearing system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFOActive Implantable Bone Conduction Hearing SystemEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191921000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191921000Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical InstrumentsCochlear Americas2019-11-15PFO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09321502045063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09321502045063093215020450639321502045063

GMDN Terms#

Term, Definition table
TermDefinition
Cochlear implant system sound processorAn external component of a cochlear implant system [cochlear implant (CI)] that typically consists of a battery-powered microphone/transmitter (transducer) designed to convert sound waves from the environment into electrical signals which are transmitted to the implantable portion of the system, via a coil (which may or may not be included), for the partial restoration of auditory sensation in a severely/profoundly deaf person. Also known as a speech processor, it is typically worn like a behind-the-ear (BTE) or off-the-ear (OTE) hearing aid.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
750551194
Device count
1
Kit
true
Serial number
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05712149025459SentioOticon Medical ABPFO2024-07-22
05712149025466SentioOticon Medical ABPFO2024-07-22
05712149025473SentioOticon Medical ABPFO2024-07-22
05712149025480SentioOticon Medical ABPFO2024-07-22
05712149025497SentioOticon Medical ABPFO2024-07-22
05712149025503SentioOticon Medical ABPFO2024-07-22
05712149026906SentioOticon Medical ABPFO2024-07-22
09321502074131OSIA FITTING SOFTWARE 2 CDCochlear Americas CorporationPFO2024-01-03
09321502070409Osia 2(I) Sound Processor kitCOCHLEAR LIMITEDPFO2023-09-15
09321502070676Osia OSI300 ImplantCOCHLEAR LIMITEDPFO2023-09-15
09321502070683Cochlear™ Magnet CassetteCOCHLEAR LIMITEDPFO2023-09-15
09321502070959Osia 2(I) SP Magnet strength 1(I)COCHLEAR LIMITEDPFO2023-09-15
09321502070966Osia 2 (I) SP Magnet strength 2(I)COCHLEAR LIMITEDPFO2023-09-15
09321502070973Osia 2(I) SP Magnet strength 3(I)COCHLEAR LIMITEDPFO2023-09-15
09321502070980Osia 2(I) SP Magnet strength 4(I)COCHLEAR LIMITEDPFO2023-09-15
09321502070997Osia 2(I) SP Magnet (I) ToolCOCHLEAR LIMITEDPFO2023-09-15
09008737525323SAMBA 2 BB PoM, rightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2023-07-05
09008737525330SAMBA 2 BB PoM, leftMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2023-07-05
09008737532925SAMBA 2 GO w/o manualsMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2022-11-16
09321502065924Cochlear™ MRI KitCOCHLEAR LIMITEDPFO2022-08-10
09321502046527Cochlear™ Sterile Non-Magnetic PlugCOCHLEAR LIMITEDPFO2021-03-09
09321502046534Cochlear™ Sterile Replacement MagnetCOCHLEAR LIMITEDPFO2021-03-09
09008737520472SAMBA 2 Remote (Android)Med-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2020-09-08
09008737525033SYMFIT 8.0 DownloadMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2020-09-08
09008737525071SAMBA 2 GOMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2020-09-08
09008737525262SAMBA 2 BB AP Unit, rightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2020-09-08
09008737525279SAMBA 2 BB AP Unit, leftMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2020-09-08
09008737525811SYMFIT 8.0 DVDMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2020-09-08
09008737525859SYMFIT 8.0 USBMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2020-09-08
09008737526030SAMBA 2 Remote (iOS)Med-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2020-09-08