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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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Prescription Digital Therapeutic for the Treatment of Pediatric Amblyopia
Luminopia, Inc.
2.0
In Commercial Distribution

  • 00860007887123 ()


  • Vision training software
Prescription Digital Therapeutic for the Treatment of Pediatric Amblyopia - 90 Day
Luminopia, Inc.
2.0
In Commercial Distribution

  • 00860007887116 ()


  • Vision training software
Prescription Digital Therapeutic for the Treatment of Pediatric Amblyopia - 30 Day
Luminopia, Inc.
2.0
In Commercial Distribution

  • 00860007887109 ()


  • Vision training software
No Description
Qr8 Health Inc
CHR-COG-20
In Commercial Distribution

  • 00860007318795 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
SNP-COG-22
In Commercial Distribution

  • 00860007318757 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
CHR-COG-W10
Not in Commercial Distribution

  • 00860007318726 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
SNP-COG-20
Not in Commercial Distribution

  • 00860007318719 ()


  • Cognitive assessment software
Critical Alert CommonPath Enterprise (CommonPath) is a software application installed on a Windows server environment capable of acquiring alarms, events, and parameters from clinical systems and intelligently forwarding this information as notifications to designated display devices provided by third-party mobile device companies.
Critical Alert
In Commercial Distribution

  • 00860006582005 ()


  • Alarm application software
No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586349 ()


  • Radiological PACS software
No Description
Oncospace, Inc.
System
In Commercial Distribution

  • 00860004284901 ()


  • Radiation therapy software
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