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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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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.
160 Channel
In Commercial Distribution

  • 00850011306789 ()
36-0301-0034

  • 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.
128 Channel
In Commercial Distribution

  • 00850011306772 ()
36-0301-0033

  • 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.
96 Channel
In Commercial Distribution

  • 00850011306765 ()
36-0301-0032

  • 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.
64 channel
In Commercial Distribution

  • 00850011306758 ()
36-0301-0031

  • 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.
32 channel
In Commercial Distribution

  • 00850011306741 ()
36-0301-0030

  • Electroencephalographic monitoring system
The Global Reference Module provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference Connection on the ATLAS Combo Board.
NEURALYNX, INC.
Global Reference Module - 1
In Commercial Distribution

  • 00850011306734 ()
31-0604-0043

  • Electroencephalographic signal amplifier
Computer ethernet connection; 7m in length.
NEURALYNX, INC.
7m
In Commercial Distribution

  • 00850011306727 ()
31-0204-0002

  • Electrical-only medical device connection cable, reusable
Computer ethernet connection; 2m in length.
NEURALYNX, INC.
2m
In Commercial Distribution

  • 00850011306710 ()
31-0204-0001

  • Electrical-only medical device connection cable, reusable
Control software for the ATLAS Stim Headbox.
NEURALYNX, INC.
1.5.1
Not in Commercial Distribution

  • 00850011306703 ()
36-0301-0006

  • Somatosensory electrical stimulation system
Accessory to the ATLAS Cart, which is part of the ATLAS Neurophysiology System.
NEURALYNX, INC.
ATLAS Cart BNC Adapter Plate
In Commercial Distribution

  • 00850011306697 ()
31-0604-0086

  • Electroencephalographic signal amplifier
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