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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

CNS Vital Signs Cognitrax - 00860013886134

CNS Vital Signs cognitive testing web platform. A limited set of cognitive tests and clinical questionnaires with audio instructions that can be administered in office.
CNS Vital Signs, LLC
1.1.4
In Commercial Distribution

  • 00860013886134 ()


  • Psychological assessment software

CNS Vital Signs Local - 00860013886110

CNS Vital Signs cognitive testing installed local software platform. A set of cognitive tests and clinical questionnaires administered in office without an internet connection.
CNS Vital Signs, LLC
4.0.107
In Commercial Distribution

  • 00860013886110 ()


  • Psychological assessment software

CNS Vital Signs Web - 00860013886103

CNS Vital Signs cognitive testing web platform. A set of cognitive tests and clinical questionnaire that can be administered in office or remotely.
CNS Vital Signs, LLC
2.0.6
In Commercial Distribution

  • 00860013886103 ()


  • Psychological assessment software

eRAD PACS - 00866994000255

eRAD PACS v9
Erad, Inc.
9
In Commercial Distribution

  • 00866994000255 ()


  • Radiological PACS software

eRAD PACS Evolution - 00866994000224

eRAD PACS Evolution
Erad, Inc.
8.0
In Commercial Distribution

  • 00866994000224 ()


  • Radiological PACS software

eRAD PACS - 00866994000200

eRAD PACS v7.2
Erad, Inc.
7.2
In Commercial Distribution

  • 00866994000200 ()


  • Radiological PACS software

Standard Imaging IMSure QA Software - 00866562000229

Standard Imaging IMSure QA Software is a stand alone software medical device used for monitor unit secondary checks and IMRT treatment plan secondary checks of radiation treatment plans from radiation therapy systems.
STANDARD IMAGING INC.
v3
In Commercial Distribution

  • 00866562000229 ()
91326

  • Radiation therapy software

Oncospace - 00860004284901

No Description
Oncospace, Inc.
System
In Commercial Distribution

  • 00860004284901 ()


  • Radiation therapy software

Luminopia - 00860007887123

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

  • 00860007887123 ()


  • Vision training software
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