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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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Canvas Dx is a prescription diagnostic aid to healthcare professionals (HCP) considering the diagnosis of Autism Spectrum Disorder (ASD) in patients 18 months through 72 months of age at risk for developmental delay. The patient’s caregiver uses a smartphone application (“App”) to fill out a caregiver questionnaire and to make video recordings of behavior at home, and then the physician fills out a medical questionnaire online. The results are made available to the physician.
Cognoa, Inc.
1.3.0
In Commercial Distribution

  • 00860007260605 ()


  • Neurodevelopmental disorder interpretive software
EXPRESSFIT PRO 2019.1
Sonic Innovations, Inc.
196004
In Commercial Distribution

  • 05711583033488 ()


  • Audiometric/hearing device software
EXPRESSFIT PRO 2018.2
Sonic Innovations, Inc.
190061
In Commercial Distribution

  • 05711583031903 ()


  • Audiometric/hearing device software
OASIS NXT 2019.1 COSTCO
Bernafon AG
196003
In Commercial Distribution

  • 05711584094082 ()


  • Audiometric/hearing device software
OASIS NXT 2019.1
Bernafon AG
196002
In Commercial Distribution

  • 05711584094075 ()


  • Audiometric/hearing device software
OASIS NXT 2019.1 CUSTOM
Bernafon AG
196001
In Commercial Distribution

  • 05711584094068 ()


  • Audiometric/hearing device software
OASIS NXT 2018.2 COSTCO
Bernafon AG
190054
In Commercial Distribution

  • 05711584086353 ()


  • Audiometric/hearing device software
OASIS NXT 2018.2
Bernafon AG
190056
In Commercial Distribution

  • 05711584085363 ()


  • Audiometric/hearing device software
OASIS NXT 2018.2 CUSTOM
Bernafon AG
190055
In Commercial Distribution

  • 05711584085356 ()


  • Audiometric/hearing device software
OASIS NXT 2017.2 COSTCO
Bernafon AG
186358
In Commercial Distribution

  • 05711584083215 ()


  • Audiometric/hearing device software
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