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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 - 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

Alpine BioMed - 05704736008754

Keypoint G4, FRA
Alpine Biomed ApS
9031A070102
Not in Commercial Distribution

  • 05704736008754 ()


  • Electromyograph

Alpine BioMed - 05704736008747

Keypoint G4, Intl. 230V ENG
Alpine Biomed ApS
9031A070101
Not in Commercial Distribution

  • 05704736008747 ()


  • Electromyograph

Alpine BioMed - 05704736008730

Keypoint G4, Intl. 115V ENG
Alpine Biomed ApS
9031A0701HA
Not in Commercial Distribution

  • 05704736008730 ()


  • Electromyograph

Alpine BioMed - 05704736008723

Keypoint G4, ENG
Alpine Biomed ApS
9031A0701BV
Not in Commercial Distribution

  • 05704736008723 ()


  • Electromyograph

Alpine BioMed - 05704736008716

Keypoint G4, US 115V
Alpine Biomed ApS
9031A0701AA
Not in Commercial Distribution

  • 05704736008716 ()


  • Electromyograph

Alpine BioMed - 05704736007320

"Demo HaspKey (USB Dongle) For demo of Keypoint Classic and Keypoint.NET Including 1 year license"
Alpine Biomed ApS
9031G0186
Not in Commercial Distribution

  • 05704736007320 ()


  • Electromyograph

Alpine Biomed - 05704736006712

PS 100-240VAC/24VDC/100-240VAC
Alpine Biomed ApS
9080D1094
Not in Commercial Distribution

  • 05704736006712 ()


  • Electromyograph

Alpine BioMed - 05704736002592

Power Supply Unit
Alpine Biomed ApS
9031D0303
Not in Commercial Distribution

  • 05704736002592 ()


  • Electromyograph

Alpine Biomed - 05704736002431

Tendon Hammer
Alpine Biomed ApS
9031E0402
Not in Commercial Distribution

  • 05704736002431 ()


  • Electromyograph

Alpine Biomed - 05704736002400

Calibrated Acoustic Screened Headset
Alpine Biomed ApS
9031E0268
Not in Commercial Distribution

  • 05704736002400 ()


  • Electromyograph

Alpine BioMed - 05704736002288

2-channel EMG/EP Amplifier with 1.7 m cable
Alpine Biomed ApS
9031C0503
Not in Commercial Distribution

  • 05704736002288 ()


  • Electromyograph

Alpine BioMed - 05704736001830

KEYPOINT WORKSTATION GE
Alpine Biomed ApS
9031A006503
Not in Commercial Distribution

  • 05704736001830 ()


  • Electromyograph

Alpine BioMed - 05704736001809

KEYPOINT WORKSTATION INT. 115 VOLT,US VER.W/O US SOFT.
Alpine Biomed ApS
9031A0065HA
Not in Commercial Distribution

  • 05704736001809 ()


  • Electromyograph

Alpine Biomed - 05704736000680

ADAPT,2MM M X 1.5MM M TP,BLACK
Alpine Biomed ApS
9030L1032
Not in Commercial Distribution

  • 05704736000680 ()


  • Electromyograph
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