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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 - 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
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