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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 - 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

Richmar EMG Software - 00092237626573

Richmar EMG Software
COMPASS HEALTH BRANDS CORP.
EMG-SW
In Commercial Distribution

  • 00092237626573 ()


  • Electromyograph

FREEEMG - B179FE3

BTS FREEEMG 300 is a wireless surface electromyograph, which makes the selection of muscles, the setting of duration and frequency of acquisition, amplification gain and the correct positioning of electrodes, simple and rapid.
BTS SPA
300
In Commercial Distribution

  • B179FE31 ()
  • B179FE3 ()
BTSFE3

  • Electromyograph

Sun Nuclear Tissue Mimicking Phantom - B136411LE0

No Description
SUN NUCLEAR CORP.
TMM
In Commercial Distribution

  • B136411LE0 ()


  • Diagnostic ultrasound phantom, test object

Sun Nuclear Sono403 Multi-Purpose Phantom SCG - B136403GSLE0

No Description
SUN NUCLEAR CORP.
403GSLE
In Commercial Distribution

  • B136403GSLE0 ()


  • Diagnostic ultrasound phantom, test object

TMJOINT - B179TMJ

BTS TMJOINT is a wireless surface electromyograph to measure the differential influence of the occlusal function through indices validated and published in scientific literature
BTS SPA
1.0
In Commercial Distribution

  • B179TMJ1 ()
  • B179TMJ ()
BTSEMB1BM

  • Electromyograph

TEETHAN - B179THN2

Indication for use: To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter To clinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity of muscles of the stomatognathic system To measure relative (intra-patient) levels of activity of 2 muscles during a functional act
BTS SPA
2.0
In Commercial Distribution

  • B179THN1 ()
  • B179THN2 ()
BTSEMB1BM

  • Electromyograph

OMNIsEMG - B179OMN

BTS OMNIsEMG is an instrument for the electromyographic surface analysis.
BTS SPA
1.0
In Commercial Distribution

  • B179OMN ()
BTSEMB1BM

  • Electromyograph
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