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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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Kintinuum™ - B493SW0043

Web application
MC10, INC.
SW-0043
Not in Commercial Distribution

  • B493SW0043 ()


  • Electronic goniometer/kinesiology sensor
  • Kinesiology ambulatory recorder
  • Biomechanical function analysis/rehabilitation software

BioStamp nPoint™ - B493SW0028

Web application
MC10, INC.
SW-0028
Not in Commercial Distribution

  • B493SW0028 ()


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

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

Compression Stocking - G420021

Web Spacer
Gottfried Medical, Inc.
021
In Commercial Distribution

  • G420021 ()
021

  • Compression/pressure glove

Kinesis Gait - 05391542950010

Kinesis Gait consists of a device for assessment of gait and movement through quantitative analysis of gait using body-worn inertial sensors. The device streams data over a Bluetooth interface to an Android tablet device.
KINESIS
2.0.1
In Commercial Distribution

  • 05391542950010 ()


  • Gait analysis system

Zyppah - 00866868000381

No Description
A.M.A. PLASTICS
Edge to Edge
In Commercial Distribution

  • 00866868000381 ()
ZHA-100-01

  • Mandible-repositioning sleep-disordered breathing orthosis

Adapter - 00854515008439

No Description
Unique Surgical
M8 to M10
In Commercial Distribution

  • 00854515008439 ()
1182

  • Orthopaedic implant-instrument extension adaptor, reusable

TR Optics - 00781096319053

Spectacle Frame, Size 55-17-145
MCGEE GROUP, INC., THE
TO Lincoln Gold
In Commercial Distribution

  • 00781096319053 ()
TRLINCOLN0GOLD0SUN

  • Spectacle frame

TR Optics - 00781096319046

Spectacle Frame, Size 48-22-140
MCGEE GROUP, INC., THE
TO Boston Silver
In Commercial Distribution

  • 00781096319046 ()
TRBOSTON0SILV0SUN

  • Spectacle frame

TR Optics - 00781096319039

Spectacle Frame, Size 48-22-140
MCGEE GROUP, INC., THE
TO Boston Gold
In Commercial Distribution

  • 00781096319039 ()
TRBOSTON0GOLD0SUN

  • Spectacle frame
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