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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™ - B493BRCT01

Mobile application tablet
MC10, INC.
BRCT01
Not in Commercial Distribution

  • B493BRCT01 ()


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

BioStamp® - B493BRCS02

Wearable sensor patch
MC10, INC.
BRCS02
Not in Commercial Distribution

  • B493BRCS02 ()


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

BioStamp® - B493BRCP03

Mobile application phone
MC10, INC.
BRCP03
Not in Commercial Distribution

  • B493BRCP03 ()


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

BioStamp nPoint™ - B493BRCP02

Mobile application phone
MC10, INC.
BRCP02
Not in Commercial Distribution

  • B493BRCP02 ()


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

BioStamp nPoint™ - B493BRCP01

Mobile application phone
MC10, INC.
BRCP01
Not in Commercial Distribution

  • B493BRCP01 ()


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

BioStamp® - B493BRCD02

Link Hub smart charger
MC10, INC.
BRCD02
Not in Commercial Distribution

  • B493BRCD02 ()


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

BioStamp nPoint™ - B493BRCD01

Link Hub smart charger
MC10, INC.
BRCD01
Not in Commercial Distribution

  • B493BRCD01 ()


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

BioStamp® - B493BRCA05

Adhesive applicator
MC10, INC.
BRCA05
Not in Commercial Distribution

  • B493BRCA05 ()


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

BioStamp® - B493BRCA02

Adhesive with hydrogel
MC10, INC.
BRCA02
Not in Commercial Distribution

  • B493MC0009 ()
  • B493BRCA02 ()


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

Aggreguide - 00856893004065

Whole Blood Aggregometer
AGGREDYNE, INC.
A-100
In Commercial Distribution

  • 00856893004041 ()
  • 00856893004065 ()
  • 00856893004003 ()


  • Platelet aggregation analyser IVD, automated
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