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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ACTIVE HANDGRIP FOR KP G3
Alpine Biomed ApS
9031E0155
Not in Commercial Distribution

  • 05704736019330 ()


  • Electromyograph
Cable kit for Focus Main Unit
Alpine Biomed ApS
9033A1801
Not in Commercial Distribution

  • 05704736019170 ()


  • Electromyograph
KP FOCUS PC SYSTEM, UK 230V SPECIAL LABELING FOR CHINA
Alpine Biomed ApS
9033A0721CN
Not in Commercial Distribution

  • 05704736019163 ()


  • Electromyograph
Keypoint G4, CHINA
Alpine Biomed ApS
9031A0701CN
Not in Commercial Distribution

  • 05704736019156 ()


  • Electromyograph
KP Focus Notebook, UK 230V special for China
Alpine Biomed ApS
9033A0711CN
Not in Commercial Distribution

  • 05704736019149 ()


  • Electromyograph
FRONT END BOX, KEYPOINT G4
Alpine Biomed ApS
9031G0703
Not in Commercial Distribution

  • 05704736019064 ()


  • Electromyograph
FOCUS MAIN UNIT
Alpine Biomed ApS
9033G0703
Not in Commercial Distribution

  • 05704736019026 ()


  • Electromyograph
6-ch. EP Amplifier
Alpine Biomed ApS
9031C0771
Not in Commercial Distribution

  • 05704736018418 ()


  • Electromyograph
Multi CC Stim
Alpine Biomed ApS
9031E0722
Not in Commercial Distribution

  • 05704736018401 ()


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

  • 05704736018395 ()


  • Electromyograph
Advanced Stimulation Handgrip
Alpine Biomed ApS
9031E0172
Not in Commercial Distribution

  • 05704736018371 ()


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

  • 05704736018319 ()


  • Electromyograph
6-ch. EMG/EP Amplifier
Alpine Biomed ApS
9031C0762
Not in Commercial Distribution

  • 05704736018302 ()


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

  • 05704736018296 ()


  • Electromyograph
FRONT END BOX, KEYPOINT G4
Alpine Biomed ApS
9031G0702
Not in Commercial Distribution

  • 05704736018272 ()


  • Electromyograph
CC STIM HANGRIP
Alpine Biomed ApS
9031E0171
Not in Commercial Distribution

  • 05704736017879 ()


  • Electromyograph
"Keypoint Focus Workstation, DAN 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
9033A072143
Not in Commercial Distribution

  • 05704736017794 ()


  • Electromyograph
Keypoint G4, French-Canadian 115V
Alpine Biomed ApS
9031A0701GN
Not in Commercial Distribution

  • 05704736017381 ()


  • Electromyograph
"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
"Keypoint Focus Workstation, NLD 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
9033A072105
Not in Commercial Distribution

  • 05704736017275 ()


  • Electromyograph
"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
"Keypoint Focus Workstation, DEU 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
9033A072103
Not in Commercial Distribution

  • 05704736017251 ()


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

  • 05704736017213 ()


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

  • 05704736017190 ()


  • Electromyograph
"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
"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
"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
"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
"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
"Keypoint Focus Notebook System, FRA Including: - Notebook PC with Keypoint software, MS Office - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A071102
Not in Commercial Distribution

  • 05704736017138 ()


  • Electromyograph
"Keypoint Focus Notebook System, Intl. 230V ENG Including: - Notebook PC with Keypoint software - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A071101
Not in Commercial Distribution

  • 05704736017121 ()


  • Electromyograph
"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
Keypoint Focus Notebook System, French-Canadian 115V
Alpine Biomed ApS
9033A0711GN
Not in Commercial Distribution

  • 05704736017107 ()


  • Electromyograph
"Keypoint Focus Notebook System, ENG Including: - Notebook PC with Keypoint software - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A0711BV
Not in Commercial Distribution

  • 05704736017091 ()


  • Electromyograph
"Keypoint Focus Notebook System, US/Canada 115V "
Alpine Biomed ApS
9033A0711AA
Not in Commercial Distribution

  • 05704736017084 ()


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

  • 05704736016865 ()


  • Electromyograph
"Keypoint Focus Module Including: - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Module kit including Keypoint software CD"
Alpine Biomed ApS
9033A0701
Not in Commercial Distribution

  • 05704736016810 ()


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

  • 05704736016742 ()


  • Electromyograph
3-ch. Focus EMG/EP Amplifier
Alpine Biomed ApS
9033C0731
Not in Commercial Distribution

  • 05704736016728 ()


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

  • 05704736016612 ()


  • Electromyograph
Isolating Transformer, 230V AC
Alpine Biomed ApS
9031D0411
Not in Commercial Distribution

  • 05704736016131 ()


  • Electromyograph
8CH. AMPLIFIER BOX.
Alpine Biomed ApS
8031C0781
Not in Commercial Distribution

  • 05704736014953 ()


  • Electromyograph
3CH. AMPLIFIER BOX.
Alpine Biomed ApS
8031C0731
Not in Commercial Distribution

  • 05704736014946 ()


  • Electromyograph
Keypoint G4
Alpine Biomed ApS
9031A0701
Not in Commercial Distribution

  • 05704736010283 ()


  • Electromyograph
CONTROL PANEL, KEYPOINT G4
Alpine Biomed ApS
9031G0711
Not in Commercial Distribution

  • 05704736010276 ()


  • Electromyograph
FRONT END BOX, KEYPOINT G4
Alpine Biomed ApS
9031G0701
Not in Commercial Distribution

  • 05704736010269 ()


  • Electromyograph
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