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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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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
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
BTS G-SENSOR 2 is a wireless system consisting of an inertial sensor composed by a tri-axial accelerometer, a magnetic sensor, and a tri-axial gyroscope, that worn by the patient allows a functional gait analysis.
BTS SPA
2
In Commercial Distribution

  • B179GSN2 ()
  • B179GSN21 ()
BTSGSN2

  • Gait analysis system
BTS FREEEMG 1000 is a wireless surface electromyograph for the acquisition and transmission of EMG signals and for the assessment of angles, angular velocities, angular accelerations and foot-floor contact areas. It allows the functional evaluation and a real-time visualization of the acquired signals for biofeedback and monitoring applications.
BTS SPA
1000
In Commercial Distribution

  • B179FR11 ()
  • B179FR1 ()
BTSEMB1BM

  • Electromyograph
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
BAIOBIT is a wireless system consisting of an inertial sensor composed by a tri-axial accelerometer, a magnetic sensor, and a tri-axial gyroscope, that worn by the patient allows a functional movement analysis.
BTS SPA
1
In Commercial Distribution

  • B179BAIO11 ()
  • B179BAIO1 ()


  • Gait analysis system
Shiga Toxin Direct Test Cartridge with sample prep device.
GREAT BASIN SCIENTIFIC, INC.
GBSTEC-10
In Commercial Distribution

  • B178GBSTEC102 ()
  • B178GBSTEC100 ()
GBSTEC-10

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
GREAT BASIN SCIENTIFIC, INC.
GBSIDR-10
In Commercial Distribution

  • B178GBSIDR102 ()
  • B178GBSIDR100 ()
GBSIDR-10

  • MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT)
  • MRSE nucleic acid detection IVD, kit, nucleic acid technique (NAT)
  • Multiple Staphylococcus bacterial species culture isolate identification IVD, kit
  • MRSA nucleic acid IVD, kit, nucleic acid technique (NAT)
Stool Bacterial Pathogens Panel Cartridge with sample prep device.
GREAT BASIN SCIENTIFIC, INC.
GBSBPP-10
In Commercial Distribution

  • B178SBPP102 ()
  • B178GBSBPP100 ()
GBSBPP-10

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
GREAT BASIN SCIENTIFIC, INC.
GBGBS-10
In Commercial Distribution

  • B178GBGBS100 ()
  • B178GBGBS102 ()
GBGBS-10

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
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