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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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ABBOTT PRISM Director Version 2.0
ABBOTT LABORATORIES
3R97-01
Not in Commercial Distribution

  • 00380740138394 ()
03R9701

  • Laboratory instrument/analyser application software IVD
Hearing Aid Feature watchOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195950095074 ()


  • Air-conduction hearing aid, in-the-ear
Hearing Aid Feature macOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195950095067 ()


  • Air-conduction hearing aid, in-the-ear
Hearing Aid Feature AirPods Pro 2 Firmware (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949149931 ()


  • Air-conduction hearing aid, in-the-ear
Hearing Aid Feature iOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949149924 ()


  • Air-conduction hearing aid, in-the-ear
NEUROFAX ACQUISITION, SML FRM
NIHON KOHDEN AMERICA, INC.
EEG-1260A
In Commercial Distribution

  • 00841983104329 ()
EEG-1260A

  • Electroencephalograph
EEG-1200A DESKTOP SYSTEM
NIHON KOHDEN AMERICA, INC.
EEG-1200A-DT
In Commercial Distribution

  • 00841983103995 ()
EEG-1200A-DT

  • Electroencephalograph
MEDICAL ISOLATION TRANSFORMER
NIHON KOHDEN AMERICA, INC.
A/ABC300-11MED
In Commercial Distribution

  • 00841983103988 ()
A/ABC300-11MED

  • Electroencephalograph
NEUROFAX ACQUISITION, Dell Precision Tower desktop
NIHON KOHDEN AMERICA, INC.
EEG-1200A-T
In Commercial Distribution

  • 00841983103971 ()
EEG-1200A-T

  • Electroencephalograph
EEG REVIEW SUITE, 5 USER LICENSE
NIHON KOHDEN AMERICA, INC.
NK-REVSUITE-5
In Commercial Distribution

  • 00841983103926 ()
NK-REVSUITE-5

  • Electroencephalograph
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