Vivosonic Inc

Address:222-5535 EGLINTON AVENUE WEST,TORONTO Ontario,CA

Want to know more about this Organization? Request more information now!

Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Stimulator, Auditory, Evoked Response (GWJ) (10) Audiometer (EWO) (1)

Premarket Exempt

Clear

Integrity CV-Amp - 00627908020147 Catalog Number :

Device Description : Dual channel CV-Amp for use as an accessory with the second generation Integrity Dual channel CV-Amp for use as an accessory with the second generation Integrity V500 system (DI: 00627908020017)The UDI is comprised of GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)

Device Class : 2

Duns Number: 201740425

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : No

Device Count : 1

Integrity VivoStim - 00627908020154 Catalog Number :

Device Description : Sound stimulator for use as an accessory with the second generation Integrity V5 Sound stimulator for use as an accessory with the second generation Integrity V500 system (DI: 00627908020017).The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL).

Device Class : 2

Duns Number: 201740425

Premarket Exempt : No

Product Code : GWJ

Prescription Use : No

Device Count : 1

VivoTab Electrode (3 pack) - 00627908070050 Catalog Number :

Device Description : Electrodes for use with the Integrity and Aurix system (DI: 00627908020017 and Electrodes for use with the Integrity and Aurix system (DI: 00627908020017 and 00627908080011respectively).The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10)

Device Class : 2

Duns Number: 201740425

Premarket Exempt : No

Product Code : GWJ

Prescription Use : No

Device Count : 1

VivoTab Electrode (4 pack) - 00627908070067 Catalog Number :

Device Description : Electrodes for use with the Integrity system (DI: 00627908020017).The UDI is c Electrodes for use with the Integrity system (DI: 00627908020017).The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10)

Device Class : 2

Duns Number: 201740425

Premarket Exempt : No

Product Code : GWJ

Prescription Use : No

Device Count : 1

EarDome - 00627908070074 Catalog Number :

Device Description : EarDomes (2 pack) for use with Vivosonic Screener (DI: 00627908020017).The UDI i EarDomes (2 pack) for use with Vivosonic Screener (DI: 00627908020017).The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10)

Device Class : 2

Duns Number: 201740425

Premarket Exempt : No

Product Code : GWJ

Prescription Use : No

Device Count : 1

Aurix Newborn Hearing Screening System - 00627908080011 Catalog Number :

Device Description : Main handheld unit for use with the Aurix system. The UDI is comprised of: GTIN Main handheld unit for use with the Aurix system. The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)The following devices are accessories for use with the Aurix system: 11002 Sound Stimulator DI: 0062790808002811003 Amplifier DI: 0062790808003511010 Laptop Computer DI: 00627908080042100116 Amplifier Lead Cable DI: 00627908080059ER-3A-AUX Insert Earphones DI:00627908080066100001 Electrodes DI: 00627908070067100004 Ear Domes DI: 00627908080080WA021 Tablet Computer DI: 00627908080097

Device Class : 2

Duns Number: 201740425

Premarket Exempt : No

Product Code : GWJ

Prescription Use : No

Device Count : 1

Aurix Sound Stimulator - 00627908080028 Catalog Number :

Device Description : Sound stimulator for use with the Aurix system (DI: 00627908080011).The UDI is c Sound stimulator for use with the Aurix system (DI: 00627908080011).The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)

Device Class : 2

Duns Number: 201740425

Premarket Exempt : No

Product Code : GWJ

Prescription Use : No

Device Count : 1

Aurix Amplifier - 00627908080035 Catalog Number :

Device Description : Amplifier for use with the Aurix system (DI: 00627908080011).The UDI is compris Amplifier for use with the Aurix system (DI: 00627908080011).The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)

Device Class : 2

Duns Number: 201740425

Premarket Exempt : No

Product Code : GWJ

Prescription Use : No

Device Count : 1

Aurix Laptop Computer - 00627908080042 Catalog Number :

Device Description : Laptop computer for use with Aurix system (DI: 00627908080011). The UDI is com Laptop computer for use with Aurix system (DI: 00627908080011). The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)

Device Class : 2

Duns Number: 201740425

Premarket Exempt : No

Product Code : GWJ

Prescription Use : No

Device Count : 1

Aurix Amplifier Lead Cable - 00627908080059 Catalog Number :

Device Description : Lead cable for use with the Aurix Amplifier (DI: 00627908080035) as an accessory Lead cable for use with the Aurix Amplifier (DI: 00627908080035) as an accessory to the Aurix system (DI: 00627908080011). The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)

Device Class : 2

Duns Number: 201740425

Premarket Exempt : No

Product Code : GWJ

Prescription Use : No

Device Count : 1

Previous 1 2 3 4 Next