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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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Taiwan Main Orthopaedic Biotechnology Co., Ltd.
MSI-PDL-01
In Commercial Distribution

  • 14719878713112 ()


  • Surgical planning/navigation-enhancement system
Upload and transmission software application
PREVENTICE TECHNOLOGIES, INC.
SW1004
In Commercial Distribution

  • 00852132007316 ()


  • Cardiopulmonary physiological parameter analysis software
Monitor communication software application
PREVENTICE TECHNOLOGIES, INC.
SW1003
In Commercial Distribution

  • 00852132007309 ()


  • Cardiopulmonary physiological parameter analysis software
Transmission software application
PREVENTICE TECHNOLOGIES, INC.
SW1002
In Commercial Distribution

  • 00852132007293 ()


  • Cardiopulmonary physiological parameter analysis software
Platform software application for data collection and analysis
PREVENTICE TECHNOLOGIES, INC.
SW1001
In Commercial Distribution

  • 00852132007286 ()


  • Cardiopulmonary physiological parameter analysis software
Bio-Logic Algo Supplies kit containing Flexicouplers and JellyTabs intended to be used with Natus hearing screeners.
NATUS MEDICAL INCORPORATED
011445
In Commercial Distribution

  • 00382830001885 ()
  • 00382830054485 ()
  • 00382830044110 ()
  • 00382830054782 ()
011445

  • Evoked-potential audiometer
The Scout Sport Otoacoustix Emissions Measurement System delivers controlled acoustic signals in the ear canal and measures the resulting evoked otoacoustic emissions (OAEs) that are generated by the outer hair cells of the inner ear. The Scout Sport device performs transient evoked otoacoustic emissions (TEOAE), distortion product otoacoustic emissions (DPOAE), and DPOAE input/output (I/O) tests.
NATUS MEDICAL INCORPORATED
Scout Sport
In Commercial Distribution

  • 00382830001618 ()
580-SP2191

  • Evoked-potential audiometer
The AuDX Pro Otoacoustic Emissions Measurement System is a handheld battery operated device that performs otoacoustic emissions tests. Connection to the patient's ear is via the Bio-logic ear probe. Using a combination of hardware and software, the system produces a controlled acoustic signal in the ear canal and measures the resultiing evoked emissions that are generated by the outer hair cells of the inner ear associated with normal cochlear function. The stimuli are presented via miniature receivers and the acoustic response in the external ear canal is recorded via a miniature microphone, all embedded in the Bio-logic OAE probe. The system collects and averages data samples until specified measurement parameters are achieved.
NATUS MEDICAL INCORPORATED
AuDX Pro
In Commercial Distribution

  • 00382830001595 ()
580-AXPRO1

  • Evoked-potential audiometer
The AuDX I/O Function is a Windows based softwsre application for use with the AuDX otoacoustic Emissions Measurement System. The AuDX I/O software enables the AuDX device user to perform DPOAE testing at different test frequencies, frequency ratios and intensity levels. The graphical representation of the test results in the form of stimulus level presented versus measured DPOAE level provides an effective way for the user to view and evaluate stimulus level-sensitive information about DPOAE responses.
NATUS MEDICAL INCORPORATED
AuDX
In Commercial Distribution

  • 00382830001588 ()
580-AX2191

  • Evoked-potential audiometer
Reusable Jumper Electrode cable, black
NATUS MEDICAL INCORPORATED
Jumper Cable Black
In Commercial Distribution

  • 00382830001526 ()

  • Length: 1.5 Millimeter
301004

  • Evoked-potential audiometer
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