Home GUDID 09321502070997 Osia 2(I) SP Magnet (I) Tool
Primary DI 09321502070997
Brand Osia 2(I) SP Magnet (I) Tool
Company COCHLEAR LIMITED
Model P1900829
Catalog number P1900829
Published 2023-09-15
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name PFO Active implantable bone conduction hearing system
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PFO Active Implantable Bone Conduction Hearing System Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 09321502070997 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 09321502070997 09321502070997 9321502070997
GMDN Terms# Term, Definition table Term Definition Implantable vibrator bone-conduction hearing implant system A battery-powered, electromechanical device assembly intended to compensate for impaired hearing by transmitting vibrations, from transduced sound waves, through the skull to the inner ear via an implanted vibrator. It typically consists of an externally worn microphone/sound processor, and a sterile vibrator assembly which is implanted in the skull (e.g., mastoid or temporal bone). The microphone receives sound waves and converts them into electrical signals (radio waves) which are sent to the vibrator wirelessly through the skin (transcutaneously) for the transmission of vibrations to the inner ear via bone conduction. It is used to treat conductive and mixed hearing loss.
Regulatory Flags# DUNS number 750551194 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true 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 DI Brand Model Catalog Published 09321502039864 Nucleus® 7 Processing Unit CP1000 Z544559 2017-07-07 09321502014564 Cochlear® Nucleus® CI512 cochlear Implant CI512 Z209051 2014-09-24 09321502063692 Cochlear™ Personalisation Cover P1840531 P1840531 2022-11-30 09321502063715 Cochlear™ Personalisation Cover P1840591 P1840591 2022-11-30 09321502066815 Cochlear™ Microphone Cover P1878176 P1878176 2022-11-29 09321502066822 Cochlear™ Microphone Cover P1878194 P1878194 2022-11-29 09321502066839 Cochlear™ Microphone Cover P1878177 P1878177 2022-11-29 09321502066846 Cochlear™ Microphone Cover P1878196 P1878196 2022-11-29 09321502066853 Cochlear™ Microphone Cover P1878199 P1878199 2022-11-29 09321502066860 Cochlear™ Microphone Cover P1878197 P1878197 2022-11-29 09321502006910 Nucleus Z33012 Z33012 2014-09-24 09321502053662 Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil "Black, 6cm (2 1/2"")" P1749647 2025-07-07 09321502053679 Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil "Brown, 6cm (2 1/2"")" P1749648 2025-07-07 09321502053686 Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil "Grey, 6cm (2 1/2"")" P1749649 2025-07-07 09321502053693 Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil "Sand, 6cm (2 1/2"")" P1749650 2025-07-07 09321502053709 Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil "White, 6cm (2 1/2"")" P1749651 2025-07-07 09321502053716 Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil "Silver, 6cm (2 1/2"")" P1749652 2025-07-07 09321502053785 Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil "Black, 8cm (3"")" P1749659 2025-07-07 09321502053792 Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil "Brown, 8cm (3"")" P1749660 2025-07-07 09321502053808 Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil "Grey, 8cm (3"")" P1749661 2025-07-07
Other Devices Sharing Product Codes# 
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