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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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No Description
RESOUNDANT, INC.
REFPDS19
In Commercial Distribution

  • 00850011790052 ()


  • Magnetic resonance elastography acoustic driver
No Description
RESOUNDANT, INC.
REFPDL18
In Commercial Distribution

  • 00850011790045 ()


  • Magnetic resonance elastography acoustic driver
No Description
RESOUNDANT, INC.
RESY3002-RESYSAB
In Commercial Distribution

  • 00850011790021 ()


  • Magnetic resonance elastography acoustic driver
This product contains a full conductive metal plated cloth inner shield with a durable plastic outer jacket which is easily applied over one or more ATLAS Tether cables providing both noise shielding and cable management.
NEURALYNX, INC.
8m
In Commercial Distribution

  • 00850011306970 ()
31-0604-0129

  • Facility radio-frequency shielding material
This product contains a full conductive metal plated cloth inner shield with a durable plastic outer jacket which is easily applied over one or more ATLAS Tether cables providing both noise shielding and cable management.
NEURALYNX, INC.
5m
In Commercial Distribution

  • 00850011306963 ()
31-0604-0128

  • Facility radio-frequency shielding material
The ATLAS Workstation is a computer that runs the Data Acquisition Software.
NEURALYNX, INC.
ATLAS Workstation
In Commercial Distribution

  • 00850011306949 ()
31-0004-0000

  • Electroencephalographic monitoring system
The ATLAS Workstation Monitor connects to the ATLAS Workstation (31-0004-0000).
NEURALYNX, INC.
ATLAS Workstation Monitor
In Commercial Distribution

  • 00850011306932 ()
31-0000-0002

  • Electroencephalographic monitoring system
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
512 Channel
In Commercial Distribution

  • 00850011306895 ()
36-0301-0045

  • Electroencephalographic monitoring system
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
480 Channel
In Commercial Distribution

  • 00850011306888 ()
36-0301-0044

  • Electroencephalographic monitoring system
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
448 Channel
In Commercial Distribution

  • 00850011306871 ()
36-0301-0043

  • Electroencephalographic monitoring system
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