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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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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

Alpine BioMed - 05704736017282

"Keypoint Focus Workstation, ITA 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
9033A072106
Not in Commercial Distribution

  • 05704736017282 ()


  • 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 - 05704736017268

"Keypoint Focus Workstation, SPA 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
9033A072104
Not in Commercial Distribution

  • 05704736017268 ()


  • 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 - 05704736017244

"Keypoint Focus Workstation, FRA Including: - USFF PC with Keypoint software, MS Office, 22” display - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Cart with isolating power supply - System kit"
Alpine Biomed ApS
9033A072102
Not in Commercial Distribution

  • 05704736017244 ()


  • Electromyograph

Alpine BioMed - 05704736017237

"Keypoint Focus Workstation, Intl. 230V (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
9033A072101
Not in Commercial Distribution

  • 05704736017237 ()


  • Electromyograph

Alpine BioMed - 05704736017220

"Keypoint Focus Workstation, Intl. 115V (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
9033A0721HA
Not in Commercial Distribution

  • 05704736017220 ()


  • 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 - 05704736017183

"Keypoint Focus Notebook System, DAN Including: - Notebook PC with Keypoint software - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A071143
Not in Commercial Distribution

  • 05704736017183 ()


  • 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 - 05704736000680

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

  • 05704736000680 ()


  • 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

Uroval - 00852523007062

The Uroval BRS System is used to record and display electromyogram (EMG )signals. In addition, the BRS System will determine latency time intervals of the bulbocavernosus reflex (BCR). The Uroval BRS System also has report generation capabilities. The Uroval BRS System uses a probe, with a single use disposable tip to evoke a BCR response and activate recording and timing of EMG signals. The Uroval BRS System uses pre-gelled surface electrodes to monitor the muscle activity.
UROVAL, INC.
BRS System
In Commercial Distribution

  • 00852523007062 ()
BRS01

  • Electromyograph

ME6000 - 06430035220243

ME6000 is a portable telemetry and data logger in measurement and monitoring of electromyography (EMG) and other physiological signals.
Bittium Biosignals Oy
ME6000 8ch WLAN
Not in Commercial Distribution

  • 06430035220243 ()


  • Electromyograph

ME6000 - 06430035220236

ME6000 is a portable telemetry and data logger in measurement and monitoring of electromyography (EMG) and other physiological signals.
Bittium Biosignals Oy
ME6000 4ch WLAN
Not in Commercial Distribution

  • 06430035220236 ()


  • Electromyograph

ME6000 - 06430035220205

ME6000 is a portable telemetry and data logger in measurement and monitoring of electromyography (EMG) and other physiological signals.
Bittium Biosignals Oy
ME6000 8ch
Not in Commercial Distribution

  • 06430035220205 ()


  • Electromyograph

ME6000 - 06430035220212

ME6000 is a portable telemetry and data logger in measurement and monitoring of electromyography (EMG) and other physiological signals.
Bittium Biosignals Oy
ME6000 16ch
Not in Commercial Distribution

  • 06430035220212 ()


  • Electromyograph

ME6000 - 06430035220199

ME6000 is a portable telemetry and data logger in measurement and monitoring of electromyography (EMG) and other physiological signals.
Bittium Biosignals Oy
ME6000 4ch
Not in Commercial Distribution

  • 06430035220199 ()


  • Electromyograph

FemiScan - 06430035220021

Electrode for FemiScan HomeTrainer (HTCS) device. For single patient use.
Bittium Biosignals Oy
Cover
Not in Commercial Distribution

  • 06430035220021 ()


  • Electromyograph

FemiScan - 06430035220014

FemiScan device is for monitoring and recording muscle activity of the pelvic floor muscles by using EMG-signals.
Bittium Biosignals Oy
HTCS-2
Not in Commercial Distribution

  • 06430035220014 ()


  • Electromyograph

Alpine BioMed - 00721902428531

EP HEADBOX UNIT
Alpine Biomed ApS
8031C0551
Not in Commercial Distribution

  • 00721902428531 ()


  • Electromyograph

Alpine BioMed - 00721902428524

8 CH. AMPLIFIER
Alpine Biomed ApS
8031C0521
Not in Commercial Distribution

  • 00721902428524 ()


  • Electromyograph

Alpine BioMed - 00721902428517

4 CH. AMPLIFIER
Alpine Biomed ApS
8031C0511
Not in Commercial Distribution

  • 00721902428517 ()


  • Electromyograph

Alpine BioMed - 00721902428500

2 CH. AMPLIFIER
Alpine Biomed ApS
8031C0501
Not in Commercial Distribution

  • 00721902428500 ()


  • Electromyograph

Alpine BioMed - 00681490920650

2-channel EMG/EP Amplifier with 1.7 m cable
Alpine Biomed ApS
9031C0501
Not in Commercial Distribution

  • 00681490920650 ()


  • Electromyograph

Alpine BioMed - 00681490853149

4 CH EP ADC BOARD FOR KEYPOINT
Alpine Biomed ApS
9031C5623
Not in Commercial Distribution

  • 00681490853149 ()


  • Electromyograph

Alpine BioMed - 00681490508865

4 CH. AMP.BOX/ARM, KEYPOINT
Alpine Biomed ApS
9031C0311
Not in Commercial Distribution

  • 00681490508865 ()


  • Electromyograph

CapsoCloud - 00867770000223

Web-based software for managing the CapsoCam Plus procedures used by health care providers, readers, download centers, and upload centers, also providing online video reviewing and reporting functionalities.
CAPSOVISION, INC.
2
In Commercial Distribution

  • 00867770000223 ()
CLD

  • Video capsule endoscopy system application software

CapsoView - 00867770000216

Software
CAPSOVISION, INC.
3
In Commercial Distribution

  • 00867770000216 ()
2759

  • Video capsule endoscopy system application software

Alpine BioMed - 00613994242297

KEYPOINT WS UKXP-OS
Alpine Biomed ApS
9031A006501
Not in Commercial Distribution

  • 00613994242297 ()


  • Electromyograph

HEM FS - 08717775955870

No Description
Medical Measurement Systems B.V.
HEM FS
In Commercial Distribution

  • 08717775955870 ()


  • Electromyograph

HEM - 08717775955702

No Description
Medical Measurement Systems B.V.
HEM
In Commercial Distribution

  • 08717775955702 ()


  • Electromyograph

Richmar EMG Pro - 00092237624456

Richmar EMG Pro
COMPASS HEALTH BRANDS CORP.
DQEMG
In Commercial Distribution

  • 00092237624456 ()


  • Electromyograph
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