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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 - 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 - 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

Alpine BioMed - 05704736008839

8-ch. Amplifier, G4
Alpine Biomed ApS
9031C0781
Not in Commercial Distribution

  • 05704736008839 ()


  • Electromyograph

Alpine BioMed - 05704736008822

6-ch. Amplifier, G4
Alpine Biomed ApS
9031C0761
Not in Commercial Distribution

  • 05704736008822 ()


  • Electromyograph

Alpine BioMed - 05704736008808

3ch. amplifier box
Alpine Biomed ApS
9031C0731
Not in Commercial Distribution

  • 05704736008808 ()


  • Electromyograph

Alpine BioMed - 05704736008792

Keypoint G4, ITA
Alpine Biomed ApS
9031A070106
Not in Commercial Distribution

  • 05704736008792 ()


  • Electromyograph

Alpine BioMed - 05704736008785

Keypoint G4, NLD
Alpine Biomed ApS
9031A070105
Not in Commercial Distribution

  • 05704736008785 ()


  • Electromyograph

Alpine BioMed - 05704736008778

Keypoint G4, SPA
Alpine Biomed ApS
9031A070104
Not in Commercial Distribution

  • 05704736008778 ()


  • Electromyograph

Alpine BioMed - 05704736008761

Keypoint G4, DEU
Alpine Biomed ApS
9031A070103
Not in Commercial Distribution

  • 05704736008761 ()


  • Electromyograph
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