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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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FreeStyle LibreLink - 00357599000042

FreeStyle LibreLink Android US
ABBOTT DIABETES CARE INC
71732-01
In Commercial Distribution

  • 00357599000042 ()
71732-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

Sonic - 05711583038223

SOUNDLINK 2 2.1.0 ANDROID
Sonic Innovations, Inc.
214711
In Commercial Distribution

  • 05711583038223 ()


  • Hearing aid/implant system remote control

Sonic - 05711583037462

SOUNDLINK 2 2.0 ANDROID
Sonic Innovations, Inc.
204548
In Commercial Distribution

  • 05711583037462 ()


  • Hearing aid/implant system remote control

Sonic - 05711583037400

SOUNDLINK 2 1.10 ANDROID
Sonic Innovations, Inc.
199524
In Commercial Distribution

  • 05711583037400 ()


  • Hearing aid enhanced audio device, telecommunication/multimedia

BioStamp nPoint™ - B493SW0026

Sync application for Android
MC10, INC.
SW-0027
Not in Commercial Distribution

  • B493SW0026 ()


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

Kintinuum™ - B493SW0042

Patient application for Android
MC10, INC.
SW-0042
Not in Commercial Distribution

  • B493SW0042 ()


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

BioStamp nPoint™ - B493SW0027

Investigator application for Android
MC10, INC.
SW-0027
Not in Commercial Distribution

  • B493SW0027 ()


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

BioStamp nPoint™ - B493SW0025

Link application for Android
MC10, INC.
SW-0025
Not in Commercial Distribution

  • B493SW0025 ()


  • 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™ - 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

Vscan - 00840682147101

Vscan Air for Android
GE Vingmed Ultrasound AS
Air for Android
In Commercial Distribution

  • 00840682147101 ()


  • Ultrasound imaging system application software

Lucid® - 00810068831481

Engage Android OTC Grey
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831481 ()
10094

  • Air-conduction hearing aid, receiver-in-the-ear

Lucid® - 00810068831467

Engage Android OTC Black
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831467 ()
10092

  • Air-conduction hearing aid, receiver-in-the-ear

Lucid® - 00810068831399

Engage Android OTC Beige
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831399 ()
10077

  • Air-conduction hearing aid, receiver-in-the-ear

Liberty® - 00810068830934

Custom ITC 128 Android
HEARING LAB TECHNOLOGY, LLC
ITC128-A
In Commercial Distribution

  • 00810068830934 ()
HLT-CUSITC128-A

  • Air-conduction hearing aid, canal

CARDINAL HEALTH - 10888439244908

KIT, COMMON
Cardinal Health 200, LLC
SPK692448D
In Commercial Distribution

  • 50888439244906 ()
  • 10888439244908 ()
SPK692448D

  • General surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10888439800791

KIT, COMMON
Cardinal Health 200, LLC
SP3692448H
In Commercial Distribution

  • 50888439800799 ()
  • 10888439800791 ()
SP3692448H

  • General surgical procedure kit, non-medicated, single-use

Tissue Punch - 08809728990714

Common Ø4.0
Megagen Implant Co. Ltd
R2STP40
In Commercial Distribution

  • 08809728990714 ()
R2STP40

  • Fixture/appliance dental drill bit, reusable

R2 Tray - 08809708759126

Common Short
Megagen Implant Co. Ltd
R2TRAYSE
In Commercial Distribution

  • 08809708759126 ()
R2TRAYSE

  • Fixture/appliance dental drill bit, reusable
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