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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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EP HEADBOX UNIT
Alpine Biomed ApS
8031C0551
Not in Commercial Distribution

  • 00721902428531 ()


  • Electromyograph
8 CH. AMPLIFIER
Alpine Biomed ApS
8031C0521
Not in Commercial Distribution

  • 00721902428524 ()


  • Electromyograph
4 CH. AMPLIFIER
Alpine Biomed ApS
8031C0511
Not in Commercial Distribution

  • 00721902428517 ()


  • Electromyograph
2 CH. AMPLIFIER
Alpine Biomed ApS
8031C0501
Not in Commercial Distribution

  • 00721902428500 ()


  • Electromyograph
2-channel EMG/EP Amplifier with 1.7 m cable
Alpine Biomed ApS
9031C0501
Not in Commercial Distribution

  • 00681490920650 ()


  • Electromyograph
4 CH EP ADC BOARD FOR KEYPOINT
Alpine Biomed ApS
9031C5623
Not in Commercial Distribution

  • 00681490853149 ()


  • Electromyograph
4 CH. AMP.BOX/ARM, KEYPOINT
Alpine Biomed ApS
9031C0311
Not in Commercial Distribution

  • 00681490508865 ()


  • Electromyograph
Web-based software for managing the CapsoCam Plus procedures used by health care providers, readers, download centers, and upload centers, also providing online video reviewing and reporting functionalities.
CAPSOVISION, INC.
2
In Commercial Distribution

  • 00867770000223 ()
CLD

  • Video capsule endoscopy system application software
Software
CAPSOVISION, INC.
3
In Commercial Distribution

  • 00867770000216 ()
2759

  • Video capsule endoscopy system application software
KEYPOINT WS UKXP-OS
Alpine Biomed ApS
9031A006501
Not in Commercial Distribution

  • 00613994242297 ()


  • Electromyograph
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