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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 - 05704736019330

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

  • 05704736019330 ()


  • Electromyograph

Alpine BioMed - 05704736019170

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

  • 05704736019170 ()


  • Electromyograph

Alpine BioMed - 05704736019163

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

  • 05704736019163 ()


  • Electromyograph

Alpine BioMed - 05704736019156

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

  • 05704736019156 ()


  • Electromyograph

Alpine BioMed - 05704736019149

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

  • 05704736019149 ()


  • Electromyograph

Alpine BioMed - 05704736019064

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

  • 05704736019064 ()


  • Electromyograph

Alpine BioMed - 05704736019026

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

  • 05704736019026 ()


  • Electromyograph

Alpine BioMed - 05704736018418

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

  • 05704736018418 ()


  • Electromyograph

Alpine BioMed - 05704736018401

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

  • 05704736018401 ()


  • Electromyograph

Alpine BioMed - 05704736018395

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

  • 05704736018395 ()


  • Electromyograph

Alpine BioMed - 05704736018371

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

  • 05704736018371 ()


  • Electromyograph

Alpine BioMed - 05704736018319

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

  • 05704736018319 ()


  • Electromyograph

Alpine BioMed - 05704736018302

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

  • 05704736018302 ()


  • Electromyograph

Alpine BioMed - 05704736018296

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

  • 05704736018296 ()


  • Electromyograph

Alpine BioMed - 05704736018272

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

  • 05704736018272 ()


  • Electromyograph

Alpine BioMed - 05704736017879

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

  • 05704736017879 ()


  • Electromyograph

Alpine BioMed - 05704736017794

"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

Alpine BioMed - 05704736017381

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

  • 05704736017381 ()


  • 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 - 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

Alpine BioMed - 05704736017138

"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

Alpine BioMed - 05704736017121

"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

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 - 05704736017107

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

  • 05704736017107 ()


  • Electromyograph

Alpine BioMed - 05704736017091

"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

Alpine BioMed - 05704736017084

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

  • 05704736017084 ()


  • Electromyograph

Alpine BioMed - 05704736016865

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

  • 05704736016865 ()


  • Electromyograph

Alpine BioMed - 05704736016810

"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

Alpine BioMed - 05704736016742

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

  • 05704736016742 ()


  • Electromyograph

Alpine BioMed - 05704736016728

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

  • 05704736016728 ()


  • Electromyograph

Alpine BioMed - 05704736016612

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

  • 05704736016612 ()


  • Electromyograph

Alpine BioMed - 05704736016131

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

  • 05704736016131 ()


  • Electromyograph

Alpine BioMed - 05704736014953

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

  • 05704736014953 ()


  • Electromyograph

Alpine BioMed - 05704736014946

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

  • 05704736014946 ()


  • Electromyograph

Alpine BioMed - 05704736010283

Keypoint G4
Alpine Biomed ApS
9031A0701
Not in Commercial Distribution

  • 05704736010283 ()


  • Electromyograph

Alpine BioMed - 05704736010276

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

  • 05704736010276 ()


  • Electromyograph

Alpine BioMed - 05704736010269

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

  • 05704736010269 ()


  • Electromyograph

Alpine BioMed - 05704736009195

Keypoint G4 config. kit
Alpine Biomed ApS
9031A0071
Not in Commercial Distribution

  • 05704736009195 ()


  • Electromyograph

Alpine BioMed - 05704736008853

Multi CC Stim, G4
Alpine Biomed ApS
9031E0721
Not in Commercial Distribution

  • 05704736008853 ()


  • Electromyograph

Alpine BioMed - 05704736008846

Single CC Stim, G4
Alpine Biomed ApS
9031E0711
Not in Commercial Distribution

  • 05704736008846 ()


  • Electromyograph
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