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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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Scanner S900 ARTI 230 V with scan- and basic modelling Software, PC and screen - D800SYAB0930

Scanner S900 ARTI 230 V with scan- and basic modelling Software, PC and screen
ZIRKONZAHN SRL
SYAB0930
In Commercial Distribution

  • D800SYAB0930 ()


  • Dental milling system, CAD/CAM, laboratory

Scanner S600 - D800SY0197

Scanner S600 ARTI 120 V with scan- and basic modelling software, PC and screen
ZIRKONZAHN SRL
SY0197
In Commercial Distribution

  • D800SY0197 ()


  • Dental milling system, CAD/CAM, laboratory

Scanner S600 - D800SY0161

Scanner S600 ARTI 230 V with scan- and basic modelling Software, PC and screen
ZIRKONZAHN SRL
SY0161
In Commercial Distribution

  • D800SY0161 ()


  • Dental milling system, CAD/CAM, laboratory

BioStamp nPoint™ - G012SW0028

Web application
Medidata Solutions, Inc.
SW-0028
In Commercial Distribution



  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software

BioStamp nPoint™ - G012SW0027

Investigator application for Android
Medidata Solutions, Inc.
SW-0027
In Commercial Distribution



  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software

BioStamp nPoint™ - G012SW0026

Sync application for Android
Medidata Solutions, Inc.
SW-0026
In Commercial Distribution



  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software

BioStamp nPoint™ - G012SW0025

Link application for Android
Medidata Solutions, Inc.
SW-0025
In Commercial Distribution



  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software

BioStamp nPoint™ - G012MC0015

MC-0015 kit containing DIs G012BRCS02, G012BRCD02, G012BRCP03, G012BSPS01, G012BRCA05
Medidata Solutions, Inc.
MC-0015
In Commercial Distribution



  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software

BioStamp nPoint™ - G012MC0014

MC-0014 kit containing DIs G012BRCS02, G012BRCD02, G012BRCP03, G012BRCT01, G012BSPS01, G012BRCA05
Medidata Solutions, Inc.
MC-0014
In Commercial Distribution



  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software

BioStamp nPoint™ - G012MC0013

MC-0013 kit containing DIs G012BRCS02, G012BRCD02, G012BRCP03, G012BSPS01, G012BRCA05
Medidata Solutions, Inc.
MC-0013
In Commercial Distribution



  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
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