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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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)
Vivosonic Inc
11003
Not in Commercial Distribution

  • 00627908080035 ()


  • Evoked-potential audiometer
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)
Vivosonic Inc
11002
Not in Commercial Distribution

  • 00627908080028 ()


  • Evoked-potential audiometer
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: 00627908080028 11003 Amplifier DI: 00627908080035 11010 Laptop Computer DI: 00627908080042 100116 Amplifier Lead Cable DI: 00627908080059 ER-3A-AUX Insert Earphones DI:00627908080066 100001 Electrodes DI: 00627908070067 100004 Ear Domes DI: 00627908080080 WA021 Tablet Computer DI: 00627908080097
Vivosonic Inc
AURIX-1
Not in Commercial Distribution

  • 00627908080011 ()


  • Evoked-potential audiometer
EarDomes (2 pack) for use with Vivosonic Screener (DI: 00627908020017). The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10)
Vivosonic Inc
100004
In Commercial Distribution

  • 00627908070074 ()


  • Evoked-potential audiometer
Electrodes for use with the Integrity system (DI: 00627908020017). The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10)
Vivosonic Inc
100001
In Commercial Distribution

  • 00627908070067 ()


  • Evoked-potential audiometer
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)
Vivosonic Inc
100001
Not in Commercial Distribution

  • 00627908070050 ()


  • Evoked-potential audiometer
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).
Vivosonic Inc
ST-800
In Commercial Distribution

  • 00627908020154 ()


  • Evoked-potential audiometer
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)
Vivosonic Inc
A91
In Commercial Distribution

  • 00627908020147 ()


  • Evoked-potential audiometer
TDH EP headphones 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).
Vivosonic Inc
H-801
In Commercial Distribution

  • 00627908020109 ()


  • Evoked-potential audiometer
HDA-300 EP headphones 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).
Vivosonic Inc
H-800
In Commercial Distribution

  • 00627908020093 ()


  • Evoked-potential audiometer
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