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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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Aurix Software - 00627908090027

Aurix software for use with the Aurix system (DI: 00627908080011) The UDI for software is comprised of the following: GTIN + Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) (which represents the software version) UDI Application Identifier for Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) = 240
Vivosonic Inc
SWA002
Not in Commercial Distribution

  • 00627908090027 ()


  • Evoked-potential audiometer

Integrity Software - 00627908090010

Integrity software for use with the first generation Integrity V500 system (DI: 00627908010018) and the second generation of the Integrity V500 system (DI: 00627908020017). The UDI is comprised of the following: GTIN + Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) (which represents the software version) UDI Application Identifier for Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) = 240
Vivosonic Inc
SWA001
In Commercial Distribution

  • 00627908090010 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer

SeeMore Software - 00850921007172

SeeMore Software 4.4.x
INTERSON CORP
4.4.x
In Commercial Distribution

  • 00850921007172 ()


  • Extracorporeal ultrasound imaging transducer, hand-held

SeeMore Software - 00850921007165

SeeMore Software 4.2.1 Urology
INTERSON CORP
4.2.1 URO
In Commercial Distribution

  • 00850921007165 ()
98-3528-03

  • Extracorporeal ultrasound imaging transducer, hand-held

SeeMore Software - 00850921007158

SeeMore Software 4.2.1 Generic
INTERSON CORP
4.2.1 GEN
In Commercial Distribution

  • 00850921007158 ()
98-3528-02

  • Extracorporeal ultrasound imaging transducer, hand-held

SeeMore Software - 00850921007141

SeeMore Software 4.2.1 OB GYN
INTERSON CORP
4.2.1 OB GYN
In Commercial Distribution

  • 00850921007141 ()
98-3528-01

  • Extracorporeal ultrasound imaging transducer, hand-held

SeeMore Software - 00850921007110

SeeMore Software 2.0.03 OB GYN
INTERSON CORP
2.0.03 OB GYN
In Commercial Distribution

  • 00850921007110 ()
98-3517-03

  • Extracorporeal ultrasound imaging transducer, hand-held

SeeMore Software - 00850921007103

SeeMore Software 2.0.03 Generic
INTERSON CORP
2.0.03 GEN
In Commercial Distribution

  • 00850921007103 ()
98-3517-00

  • Extracorporeal ultrasound imaging transducer, hand-held

SeeMore Software - 00850921007066

SeeMore Software 2.0.03 Urology
INTERSON CORP
2.0.03 URO
In Commercial Distribution

  • 00850921007066 ()
98-3517-02

  • Extracorporeal ultrasound imaging transducer, hand-held

CERVELLO SOFTWARE - 00850154007086

Cervello Software for use with Blackrock Neuromed systems, version 1.04 and all sub releases.
BLACKROCK NEUROMED, LLC
RS-0003
In Commercial Distribution

  • 00850154007086 ()
RS-0003

  • Electroencephalography telemetric monitoring system
  • Bioelectrical signal analysis software
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