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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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NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach System - 00850015518294

Controller. The NaviCam Xpress Stomach System is a endoscopic capsule imaging system intended to obtain images of the stomach. It differs from passive capsule endoscopy systems in that it uses magnetic fields to allow the position of the capsule within the stomach to be controlled by an operator
ANX ROBOTICA CORP
Controller/ NaviEC-2000
In Commercial Distribution

  • 00850015518294 ()
MC-US-1002

  • Video capsule endoscopy system capsule magnetic manipulation unit

Alpine BioMed - 00613994242297

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

  • 00613994242297 ()


  • Electromyograph

PillSense Receiver - 05391539210073

The PillSense Receiver collects and displays real-time information gathered by the PillSense Capsule. The PillSense Receiver interprets the data and displays a result message “Blood Detected” or “No Blood Detected”.
ENTERASENSE LIMITED
P00167-01FP
In Commercial Distribution

  • 05391539210073 ()


  • Gastrointestinal telemetric monitoring system receiver

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
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