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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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Integrity Insert Earphones - 00627908020086

ER-3C insert earphones 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
ER-3C-800
In Commercial Distribution

  • 00627908020086 ()


  • Evoked-potential audiometer

Integrity Insert Earphones - 00627908020079

ER-3A insert earphones 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
ER-3A-800
In Commercial Distribution

  • 00627908020079 ()


  • Evoked-potential audiometer

Integrity Insert Earphones - 00627908020062

ER-2 insert earphones 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
ER-2-800
In Commercial Distribution

  • 00627908020062 ()


  • Evoked-potential audiometer

Integrity Bone Conductor - 00627908020055

Bone conductor 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
B71W
In Commercial Distribution

  • 00627908020055 ()


  • Evoked-potential audiometer

Integrity VivoAmp - 00627908020048

Dual channel VivoAmp 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
A90
In Commercial Distribution

  • 00627908020048 ()


  • Evoked-potential audiometer

Integrity Amplitrode - 00627908020031

Dual channel Amplitrode 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
A82
In Commercial Distribution

  • 00627908020031 ()


  • Evoked-potential audiometer

Integrity Amplitrode - 00627908020024

One channel Amplitrode for use as an accessory with the second generation of the Integrity V500 system (DI: 00627908020017). The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL).
Vivosonic Inc
A81
In Commercial Distribution

  • 00627908020024 ()


  • Evoked-potential audiometer

Integrity EP Headphones - 00627908010056

HDA-300 EP headphones for use as an accessory with the first generation Integrity V500 system (DI: 00627908010018). The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
Vivosonic Inc
HDA 300
In Commercial Distribution

  • 00627908010056 ()


  • Evoked-potential audiometer

Integrity Insert Earphones - 00627908010049

ER-3A insert earphones for use as an accessory with the first generation Integrity V500 system (DI: 00627908010018). The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
Vivosonic Inc
ER-3A-ABR
In Commercial Distribution

  • 00627908010049 ()


  • Evoked-potential audiometer

Integrity Bone Conductor - 00627908010032

Bone conductor for use as an accessory with the first generation Integrity V500 system (DI: 00627908010018). The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
Vivosonic Inc
B71-10
In Commercial Distribution

  • 00627908010032 ()


  • Evoked-potential audiometer
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