FDA.reportPublic FDA data

Cochlear™ MRI Kit

Primary DI
09321502065924
Brand
Cochlear™ MRI Kit
Company
COCHLEAR LIMITED
Model
P1890818
Catalog number
P1890818
Published
2022-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
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
K220922000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220922000Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI KitCochlear Americas2022-07-27PFO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09321502065924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09321502065924093215020659249321502065924

GMDN Terms#

Term, Definition table
TermDefinition
Facility magnetic field shielding materialA radiation protection device in the form of magnetically conductive material used in conjunction with medical devices in a medical facility, to form a barrier to contain magnetic field lines, and protect people or electronic equipment from magnetic effects. This kind of shielding is intended to permit electronic equipment to be operated closer than otherwise possible to large magnetic fields, e.g., those associated with magnetic resonance imaging (MRI) systems.

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
Expiration 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
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
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
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
09008737526115SAMBA 2 BB User Kit, rightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2020-09-08