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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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SedLine Module
MASIMO CORPORATION
4497
In Commercial Distribution

  • 00843997013895 ()
4497

  • Patient monitoring system module, electroencephalographic
Quatro Sensor Kit, (25) 186-0106
Covidien LP
186-0106-PH
In Commercial Distribution

  • 90884521657515 ()
  • 30884521134502 ()


  • Anaesthesia depth monitor
Quatro Sensor Kit, (25) 186-0106
Covidien LP
186-0106-PH
In Commercial Distribution

  • 20884521134505 ()
  • 30884521134502 ()


  • Anaesthesia depth monitor
IntelliVue XDS Software
Philips Medizin Systeme Böblingen GmbH
IntelliVue XDS Software
In Commercial Distribution

  • 00884838059313 ()
867019

  • Bedside information system application software
NexSpeech Analyzer Software
Nexstim Oyj
2
In Commercial Distribution

  • 06430063200033 ()


  • Stereotactic neuronavigation/planning system
  • Hand-held deep-tissue electromagnetic stimulator
  • Electromyograph
NBS main software
Nexstim Oyj
5
In Commercial Distribution

  • 06430063200002 ()


  • Hand-held deep-tissue electromagnetic stimulator
  • Electromyograph
  • Stereotactic neuronavigation/planning system
Software Revision 15.5
Philips Ultrasound LLC
989606720441
In Commercial Distribution

  • 00884838103603 ()


  • Radiological PACS software
IntelliVue XDS Software
Philips Medizin Systeme Böblingen GmbH
IntelliVue XDS Software
In Commercial Distribution

  • 00884838092099 ()
867019

  • Bedside information system application software
IntelliVue XDS Software
Philips Medizin Systeme Böblingen GmbH
IntelliVue XDS Software - R
In Commercial Distribution

  • 00884838123175 ()
867019

  • Bedside information system application software
Software Version 10.0.2
Philips Ultrasound LLC
795119
In Commercial Distribution

  • 00884838114258 ()


  • General-purpose ultrasound imaging system
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