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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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InTandem - 00860001790801

InTandem is indicated to improve walking and ambulation in adult chronic stroke patients. InTandem is intended to be used in the home for the physical rehabilitation of ambulatory adults with chronic stroke walking impairments.
Medrhythms, Inc.
0010
In Commercial Distribution

  • 00860001790801 ()


  • Neuromuscular rehabilitation software

UltraMANAGEMENT UTILITY - 00860001148596

UltraRAD Product User Web Interface
ULTRARAD CORPORATION
2.0.2.8
In Commercial Distribution



  • Radiological PACS software

UltraMANAGEMENT UTILITY - 00860001148589

UltraRAD Product User Web Interface
ULTRARAD CORPORATION
1.0.0.12
In Commercial Distribution

  • 00860001148589 ()


  • Radiological PACS software

UltraBROKER - 00860001148572

DICOM Modality Worklist
ULTRARAD CORPORATION
3.0.2.362
In Commercial Distribution

  • 00860001148572 ()


  • Radiological PACS software

TRAQinform IQ 2 - 00860007104916

No Description
Aiq Global, Inc.
2.x
In Commercial Distribution

  • 00860007104916 ()


  • Radiological PACS software

CommonPath Enterprise - 00860006582005

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

Luminopia - 00860007887123

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

  • 00860007887123 ()


  • Vision training software

Luminopia - 00860007887116

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

  • 00860007887116 ()


  • Vision training software

Luminopia - 00860007887109

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

  • 00860007887109 ()


  • Vision training software

3D Brachy Application - 00860007402326

3D Brachy Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during surface brachytherapy. The use of 3D Brachy application is by prescription only.
Adaptiiv Medical Technologies Inc
v2021.1.0
In Commercial Distribution

  • 00860007402326 ()


  • Radiation therapy software
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