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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 Wave - 00840067101209

Sierra Wave Stimtroller
CADWELL INDUSTRIES, INC.
190217-200
In Commercial Distribution

  • 00840067101209 ()


  • Electromyograph

Sierra Wave - 00840067100769

Amp-Stim Switch Box
CADWELL INDUSTRIES, INC.
190266-200
In Commercial Distribution

  • 00840067100769 ()


  • Electromyograph

Cascade Elite - 00840067100578

Cascade VEP/LED Quick Connect Goggles
CADWELL INDUSTRIES, INC.
199253-200
In Commercial Distribution

  • 00840067100578 ()


  • Electromyograph

Sierra Wave - 00840067100547

SII Bone Vibrator
CADWELL INDUSTRIES, INC.
199224-200
In Commercial Distribution

  • 00840067100547 ()


  • Electromyograph

Sierra Wave - 00840067100530

Light Weight Headphones
CADWELL INDUSTRIES, INC.
199220-200
In Commercial Distribution

  • 00840067100530 ()


  • Electromyograph

Sierra Wave - 00840067100523

Acoustic Shielded Headphones
CADWELL INDUSTRIES, INC.
199219-200
Not in Commercial Distribution

  • 00840067100523 ()


  • Electromyograph

Sierra Wave - 00840067100516

Cascade VEP/LED Goggles
CADWELL INDUSTRIES, INC.
199246-200
In Commercial Distribution

  • 00840067100516 ()


  • Electromyograph

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
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