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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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BioStamp nPoint™ - G012MC0004

Discovery Kit containing DIs G012BRCS02, G012BRCD01, G012BRCP01, G012BRCP02, G012BRCP03, G012BRCT01, G012BSPS01, G012BRCA05, G012MC0009
Medidata Solutions, Inc.
MC-0004
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™ - G012MC0003

Exploratory Kit containing DIs G012BRCS02, G012BRCD01, G012BRCP01, G012BRCP02, G012BRCP03, G012BRCT01, G012BSPS01, G012BRCA05, G0123MC0009
Medidata Solutions, Inc.
MC0003
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® - G012BSPS01

Link Hub smart charger power supply
Medidata Solutions, Inc.
BSPS01
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® - G012BRCD02

Link Hub Smart Charger
Medidata Solutions, Inc.
BRCD02
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® - G012BRCA05

Adhesive Applicator
Medidata Solutions, Inc.
BRCA05
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™ - G012MC0012

MC-0012 kit containing DIs G012BRCS02, G012BRCD02, BG012BRCP03, G012BSPS01, G012BRCA05
Medidata Solutions, Inc.
MC-0012
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™ - G012MC0008

MC-0008 kit containing DIs G012BRCS02, G012BRCD02, G012BRCP03, G012BSPS01, G012BRCA05
Medidata Solutions, Inc.
MC-0008
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™ - G012MC0007

MC-0007 kit containing DIs G012BRCS02, G012BRCD02, G012BRCP03, G012BRCT01, G012BSPS01, G012BRCA05
Medidata Solutions, Inc.
MC-0007
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 - G012MC00022

Clinical Investigations Kit containing BRCS02 Wearable Sensor Patch, BRCD02 Smart Charger, BSPS01 Medical Power Supply, BRCA05 Adhesive Applicator, BRCP03 Phone
Medidata Solutions, Inc.
MC00022
In Commercial Distribution

  • G012MC00022 ()


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

BioStamp nPoint™ - G012BRCT01

Mobile Application tablet
Medidata Solutions, Inc.
BRCT01
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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