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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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Alpine BioMed - 05704736017213

Keypoint Focus Workstation, French-Canadian 115V
Alpine Biomed ApS
9033A0721GN
Not in Commercial Distribution

  • 05704736017213 ()


  • Electromyograph

Alpine BioMed - 05704736017206

"Keypoint Focus Workstation, ENG Including: - USFF PC with Keypoint software, 22” display - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Cart with isolating power supply - System kit"
Alpine Biomed ApS
9033A0721BV
Not in Commercial Distribution

  • 05704736017206 ()


  • Electromyograph

Alpine BioMed - 05704736017190

Keypoint Focus Workstation, US/Canada 115V
Alpine Biomed ApS
9033A0721AA
Not in Commercial Distribution

  • 05704736017190 ()


  • Electromyograph

Alpine BioMed - 05704736017176

"Keypoint Focus Notebook System, ITA Including: - Notebook PC with Keypoint software - Keypoint Focus Main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A071106
Not in Commercial Distribution

  • 05704736017176 ()


  • Electromyograph

Alpine BioMed - 05704736017169

"Keypoint Focus Notebook System, NLD Including: - Notebook PC with Keypoint software - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A071105
Not in Commercial Distribution

  • 05704736017169 ()


  • Electromyograph

Alpine BioMed - 05704736017152

"Keypoint Focus Notebook System, SPA Including: - Notebook PC with Keypoint software - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A071104
Not in Commercial Distribution

  • 05704736017152 ()


  • Electromyograph

Alpine BioMed - 05704736017114

"Keypoint Focus Notebook System, Intl. 115V ENG Including: - Notebook PC with Keypoint software - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A0711HA
Not in Commercial Distribution

  • 05704736017114 ()


  • Electromyograph

Alpine BioMed - 05704736016865

6CH. AMPLIFIER BOX.
Alpine Biomed ApS
8031C0761
Not in Commercial Distribution

  • 05704736016865 ()


  • Electromyograph

Alpine BioMed - 05704736016742

Isolating Transformer, 115V  
Alpine Biomed ApS
9031D0401
In Commercial Distribution

  • 05704736016742 ()


  • Electromyograph

Alpine BioMed - 05704736016612

ACTIVE HANDGRIP FOR KP G3
Alpine Biomed ApS
9031E0154
Not in Commercial Distribution

  • 05704736016612 ()


  • Electromyograph
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