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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 - 05704736018395

Single CC Stim
Alpine Biomed ApS
9031E0712
Not in Commercial Distribution

  • 05704736018395 ()


  • Electromyograph

Alpine BioMed - 05704736018319

8-ch. EMG/EP Amplifier
Alpine Biomed ApS
9031C0782
Not in Commercial Distribution

  • 05704736018319 ()


  • Electromyograph

Alpine BioMed - 05704736018296

3ch. amplifier box
Alpine Biomed ApS
9031C0732
Not in Commercial Distribution

  • 05704736018296 ()


  • Electromyograph

Alpine BioMed - 05704736017282

"Keypoint Focus Workstation, ITA 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
9033A072106
Not in Commercial Distribution

  • 05704736017282 ()


  • Electromyograph

Alpine BioMed - 05704736017268

"Keypoint Focus Workstation, SPA 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
9033A072104
Not in Commercial Distribution

  • 05704736017268 ()


  • Electromyograph

Alpine BioMed - 05704736017244

"Keypoint Focus Workstation, FRA Including: - USFF PC with Keypoint software, MS Office, 22” display - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Cart with isolating power supply - System kit"
Alpine Biomed ApS
9033A072102
Not in Commercial Distribution

  • 05704736017244 ()


  • Electromyograph

Alpine BioMed - 05704736017237

"Keypoint Focus Workstation, Intl. 230V (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
9033A072101
Not in Commercial Distribution

  • 05704736017237 ()


  • Electromyograph

Alpine BioMed - 05704736017220

"Keypoint Focus Workstation, Intl. 115V (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
9033A0721HA
Not in Commercial Distribution

  • 05704736017220 ()


  • Electromyograph

Alpine BioMed - 05704736017183

"Keypoint Focus Notebook System, DAN Including: - Notebook PC with Keypoint software - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A071143
Not in Commercial Distribution

  • 05704736017183 ()


  • Electromyograph

Alpine BioMed - 05704736017145

"Keypoint Focus Notebook System, DEU Including: - Notebook PC with Keypoint software - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A071103
Not in Commercial Distribution

  • 05704736017145 ()


  • Electromyograph
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