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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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ATLAS Stim Headbox with High Density side panel.
NEURALYNX, INC.
High Density
In Commercial Distribution

  • 00850011306345 ()
31-0601-0132

  • Somatosensory electrical stimulation system
ATLAS Stim Headbox with Touchproof side panel.
NEURALYNX, INC.
Touchproof
In Commercial Distribution

  • 00850011306338 ()
31-0601-0089

  • Somatosensory electrical stimulation system
The ATLAS High Density Signal Splitter (HDSS) is an adapter that allows signals from an electrode interface to be recorded by not only the ATLAS Neurophysiological System (K110967) by Neuralynx, Inc. but also the Quantum Amplifier by Natus Corporation. The ATLAS HDSS shares the buffered outputs from the electrode interface and routes them to both systems to be digitized.
NEURALYNX, INC.
ATLAS HDSS
In Commercial Distribution

  • 00850011306321 ()
31-0602-0031

  • Electrical-only medical device connection cable, reusable
Modular Electrode Interface for connecting 16 contact PMT MINI CONNECTOR to Modular Headstage-36 which is connected to the ATLAS Acquisition Amplifier. Modular Electrode Interface-PM16 and Modular Headstage-36 are components of the ATLAS Neurophysiology System.
NEURALYNX, INC.
MEI-PM16
In Commercial Distribution

  • 00850011306284 ()
31-0603-0024

  • Electrical-only medical device connection cable, reusable
Modular Electrode Interface for connecting 10 contact PMT MINI CONNECTOR to Modular Headstage-36 which is connected to the ATLAS Acquisition Amplifier. Modular Electrode Interface-PM10 and Modular Headstage-36 are components of the ATLAS Neurophysiology System.
NEURALYNX, INC.
MEI-PM10
In Commercial Distribution

  • 00850011306277 ()
31-0603-0022

  • Electrical-only medical device connection cable, reusable
The DIXI Adapter allows customers to use 4 electrode microwire tails (8 channels per tail) and record those 32 channels to a single ATLAS Combo board.
NEURALYNX, INC.
DIXI Adapter
In Commercial Distribution

  • 00850011306260 ()
31-0602-0041

  • Electrical-only medical device connection cable, reusable
The Ethernet Switch is a fully managed switch designed for high-performance networking in enterprise environments.
NEURALYNX, INC.
Ethernet Switch
In Commercial Distribution

  • 00850011306253 ()
31-0604-0139

  • Medical networking interface unit
The ATLAS MICROMED JB INTERFACE is a buffered interface between Micromed Jackbox and ATLAS. The ATLAS MICROMED JB INTERFACE uses electronic components to buffer single unit activity sensed by the electrodes and sends it to the ATLAS Data Acquisition System to be digitized.
NEURALYNX, INC.
ATLAS MICROMED JB INTERFACE
In Commercial Distribution

  • 00850011306246 ()
31-0601-0088

  • Electroencephalographic signal amplifier
An uninterruptible power supply that provides power to the ATLAS Neurophysiology System for up to five minutes and limits patient leakage current to an acceptable level in a rack mounted form factor.
NEURALYNX, INC.
ATLAS Rackmounted Power Isolator
In Commercial Distribution

  • 00850011306239 ()
31-0607-0015

  • Uninterruptible power supply system
The ATLAS-HS-36-CHET-IDC10 is a clinical headstage that allows four X 3M 10 Pin Receptacle Connector (e.g. 8510-4500PL) connectors to interface with the ATLAS Data Acquisition System. The ATLAS-HS-36-CHET-IDC10 uses electronic components to buffer single unit activity sensed by the electrodes and sends it to the ATLAS Data Acquisition System to be digitized.
NEURALYNX, INC.
ATLAS-HS-36-CHET-IDC10
Not in Commercial Distribution

  • 00850011306222 ()
31-0601-0087

  • Electroencephalographic signal amplifier
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