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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 - 05704736018401

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

  • 05704736018401 ()


  • Electromyograph

Alpine BioMed - 05704736018371

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

  • 05704736018371 ()


  • Electromyograph

Alpine BioMed - 05704736018302

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

  • 05704736018302 ()


  • 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 - 05704736017275

"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

Alpine BioMed - 05704736017251

"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

Alpine BioMed - 05704736017213

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

  • 05704736017213 ()


  • Electromyograph

Alpine BioMed - 05704736017206

"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

Alpine BioMed - 05704736017190

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

  • 05704736017190 ()


  • Electromyograph

Alpine BioMed - 05704736017176

"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

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 - 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 - 05704736016865

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

  • 05704736016865 ()


  • Electromyograph

Alpine BioMed - 05704736016742

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

  • 05704736016742 ()


  • Electromyograph

Alpine BioMed - 05704736016612

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

  • 05704736016612 ()


  • Electromyograph

Alpine BioMed - 05704736014953

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

  • 05704736014953 ()


  • 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 - 05704736008846

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

  • 05704736008846 ()


  • 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 - 05704736008785

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

  • 05704736008785 ()


  • Electromyograph

Alpine Biomed - 05704736006712

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

  • 05704736006712 ()


  • Electromyograph

Alpine Biomed - 05704736002417

Tubal Insert Earphones
Alpine Biomed ApS
9031E0277
Not in Commercial Distribution

  • 05704736002417 ()


  • Electromyograph

Alpine Biomed - 05704736002387

Goggles for VEP including 5 m Cable
Alpine Biomed ApS
9031E0223
Not in Commercial Distribution

  • 05704736002387 ()


  • Electromyograph

Alpine Biomed - 05704736000284

Leadpoint Stimulus Adaptor
Alpine Biomed ApS
9013C0532
Not in Commercial Distribution

  • 05704736000284 ()


  • Electromyograph

VistaPhone - 00850490007481

Vista Phone S9 relay device
Vital Connect, Inc.
8303-03
In Commercial Distribution

  • 00850490007481 ()
8303-03

  • Multiple vital physiological parameter monitoring system transceiver

SX230FW EMG Sensor - 05060481691512

The SX230FW EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. The EMG Amplifier (SX230FW) uses disposable electrodes and has a variable electrode distance. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13. SX230FW EMG Sensor (Gain 1000, Bandwidth 20-460Hz) - Metal connector
BIOMETRICS LIMITED
SX230FW
In Commercial Distribution

  • 05060481691512 ()
bandwidth 20-460 metal connector

  • Electromyograph

SX230-100 EMG Sensor - 05060481691505

The SX230-100 EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. Biometrics Ltd precision bipolar, differential EMG sensors have integral electrodes with a fixed electrode distance of 20mm. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13. SX230-100 EMG Sensor (Gain 100, Bandwidth 20-460Hz) - Metal connector
BIOMETRICS LIMITED
SX230-100
In Commercial Distribution

  • 05060481691505 ()
Gain 100, bandwidth 20-460 metal connector

  • Electromyograph

SX230-1000 EMG Sensor - 05060481691499

The SX230-1000 EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. Biometrics Ltd precision bipolar, differential EMG sensors have integral electrodes with a fixed electrode distance of 20mm. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13. SX230-1000 EMG Sensor (Gain 1000, Bandwidth 5-1000Hz) - Metal connector
BIOMETRICS LIMITED
SX230-1000
In Commercial Distribution

  • 05060481691499 ()
bandwidth 5-1000 metalconnector

  • Electromyograph

SX230-1000 EMG Sensor - 05060481691482

The SX230-1000 EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. Biometrics Ltd precision bipolar, differential EMG sensors have integral electrodes with a fixed electrode distance of 20mm..This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13. SX230-1000 EMG Sensor (Gain 1000, Bandwidth 5-480Hz) - Metal connector
BIOMETRICS LIMITED
SX230-1000
In Commercial Distribution

  • 05060481691482 ()
bandwidth 5-480 metal connector

  • Electromyograph

SX230-1000 EMG Sensor - 05060481691475

The SX230-1000 EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. Biometrics Ltd precision bipolar, differential EMG sensors have integral electrodes with a fixed electrode distance of 20mm. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13 SX230-1000 EMG Sensor (Gain 1000, Bandwidth 20-460Hz) - Metal connector
BIOMETRICS LIMITED
SX230-1000
In Commercial Distribution

  • 05060481691475 ()
bandwidth 20-460 metal connector

  • Electromyograph

SX230FW EMG Sensor - 05060481691468

The SX230FW EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. The EMG Amplifier (SX230FW) uses disposable electrodes and has a variable electrode distance. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 SX230FW EMG Sensor (Gain 1000, Bandwidth 20-460Hz) - Plastic connector
BIOMETRICS LIMITED
SX230FW
In Commercial Distribution

  • 05060481691468 ()
bandwidth 20-460 plastic connector

  • Electromyograph

SX230-100 EMG Sensor - 05060481691451

The SX230-100 EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. Biometrics Ltd precision bipolar, differential EMG sensors have integral electrodes with a fixed electrode distance of 20mm.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 SX230-100 EMG Sensor (Gain 100, Bandwidth 20-460Hz) - Plastic connector
BIOMETRICS LIMITED
SX230-100
In Commercial Distribution

  • 05060481691451 ()
Gain 100, bandwidth 20-460 plastic connector

  • Electromyograph

SX230-1000 EMG Sensor - 05060481691444

The SX230-1000 EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. Biometrics Ltd precision bipolar, differential EMG sensors have integral electrodes with a fixed electrode distance of 20mm.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 SX230-1000 EMG Sensor (Gain 1000, Bandwidth 5-1000Hz) - Plastic connector
BIOMETRICS LIMITED
SX230-1000
In Commercial Distribution

  • 05060481691444 ()
bandwidth 5-1000 plastic connector

  • Electromyograph

SX230-1000 EMG Sensor - 05060481691437

The SX230-1000 EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. Biometrics Ltd precision bipolar, differential EMG sensors have integral electrodes with a fixed electrode distance of 20mm.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 SX230-1000 EMG Sensor (Gain 1000, Bandwidth 5-480Hz) - Plastic connector
BIOMETRICS LIMITED
SX230-1000
In Commercial Distribution

  • 05060481691437 ()
bandwidth 5-480 plastic connector

  • Electromyograph

SX230-1000 EMG Sensor - 05060481691420

The SX230-1000 EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. Biometrics Ltd precision bipolar, differential EMG sensors have integral electrodes with a fixed electrode distance of 20mm.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 SX230-1000 EMG Sensor (Gain 1000, Bandwidth 20-460Hz) - Plastic connector
BIOMETRICS LIMITED
SX230-1000
In Commercial Distribution

  • 05060481691420 ()
bandwidth 20-460 plastic connector

  • Electromyograph

K Myo - 03770011995875

K Myo is a biofeedback device for training muscle groups by means of electromyography
KINVENT BIOMECANIQUE
K Myo Black V3
In Commercial Distribution

  • 03770011995875 ()


  • Electromyograph

K Myo - 03770011995707

K Myo is a biofeedback device for training muscle groups by means of electromyography
KINVENT BIOMECANIQUE
K Myo V3
In Commercial Distribution

  • 03770011995707 ()


  • Electromyograph

Manipolo di Stimolazione Elettrica 2+ - 08056446900284

Electrical Stimulation Probe for EMG/EP systems
EB NEURO SPA
B9700068100
In Commercial Distribution

  • 08056446900284 ()


  • Electromyograph
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