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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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Sierra Summit/Ascent - 00840067100356

Sierra Summit Footswitch
CADWELL INDUSTRIES, INC.
190286-200
In Commercial Distribution

  • 00840067100356 ()


  • Electromyograph

Sierra Ascent - 00840067100349

Sierra Ascent Handheld Stimulator
CADWELL INDUSTRIES, INC.
190277-200
In Commercial Distribution

  • 00840067100349 ()


  • Electromyograph

Sierra Summit/Ascent - 00840067100332

Sierra Summit VEP LED Goggles
CADWELL INDUSTRIES, INC.
199277-200
In Commercial Distribution

  • 00840067100332 ()


  • Electromyograph

Sierra Summit - 00840067100325

Sierra Summit Bone Vibrator
CADWELL INDUSTRIES, INC.
199276-200
In Commercial Distribution

  • 00840067100325 ()


  • Electromyograph

Sierra Summit - 00840067100301

Sierra Summit Remote Input Box
CADWELL INDUSTRIES, INC.
190285-200
In Commercial Distribution

  • 00840067100301 ()


  • Electromyograph

Sierra Summit - 00840067100288

VEP Cal Sensor
CADWELL INDUSTRIES, INC.
190283-200
In Commercial Distribution

  • 00840067100288 ()


  • Electromyograph

Sierra Summit - 00840067100264

RING/BAR ELECTRODE SWITCH BOX
CADWELL INDUSTRIES, INC.
190292-200
In Commercial Distribution

  • 00840067100264 ()


  • Electromyograph

Cascade Pro - 00840067100189

Cascade Pro 16Ch Amplifier
CADWELL INDUSTRIES, INC.
190265-200
In Commercial Distribution

  • 00840067100189 ()


  • Electromyograph

Sierra Ascent - 00840067100141

Sierra Ascent 2 Ch. Amplifier
CADWELL INDUSTRIES, INC.
190275-200
In Commercial Distribution

  • 00840067100141 ()


  • Electromyograph

Sierra Ascent - 00840067100134

Sierra Ascent Base
CADWELL INDUSTRIES, INC.
190273-200
In Commercial Distribution

  • 00840067100134 ()


  • Electromyograph

Sierra Summit/Ascent - 00840067100127

HDA280 Sennheiser Headphone
CADWELL INDUSTRIES, INC.
199268-200
Not in Commercial Distribution

  • 00840067100127 ()


  • Electromyograph

Sierra Summit/Ascent - 00840067100110

Summit Tendon Hammer
CADWELL INDUSTRIES, INC.
190282-200
In Commercial Distribution

  • 00840067100110 ()


  • Electromyograph

Sierra Summit - 00840067100103

Sierra Summit 2 Ch. Amplifier
CADWELL INDUSTRIES, INC.
190276-200
In Commercial Distribution

  • 00840067100103 ()


  • Electromyograph

Sierra Summit - 00840067100097

Sierra Summit 12 Ch. Amplifier
CADWELL INDUSTRIES, INC.
190280-200
In Commercial Distribution

  • 00840067100097 ()


  • Electromyograph

Sierra Summit - 00840067100035

Sierra Summit Base
CADWELL INDUSTRIES, INC.
190272-200
In Commercial Distribution

  • 00840067100035 ()


  • Electromyograph

Sierra Summit - 00840067100011

Sierra Summit StimTroller Plus
CADWELL INDUSTRIES, INC.
190274-200
In Commercial Distribution

  • 00840067100011 ()


  • Electromyograph

PULSAR - 04048551242513

KARL STORZ PULSAR II Stroboscope
Karl Storz GmbH & Co. KG
40160120
In Commercial Distribution

  • 04048551242513 ()


  • Laryngostroboscope system

PillCam - 10884521845923

PillCam (TM) Desktop Software v9.7 Upgrade
Given Imaging, Inc.
FGS-0803
In Commercial Distribution

  • 10884521845923 ()


  • Video capsule endoscopy system application software

PillCam - 10884521845916

PillCam (TM) Desktop Software v9.7
Given Imaging, Inc.
FGS-0802
In Commercial Distribution

  • 10884521845916 ()


  • Video capsule endoscopy system application software

PillCam - 10884521836181

PillCam Cloud reader Software V1.0
Given Imaging, Inc.
FGS-0707
In Commercial Distribution

  • 10884521836181 ()


  • Video capsule endoscopy system application software
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