ATLAS Patient Event Marker Patient Event Marker

GUDID 00850011306192

The ATLAS Patient Event Marker is an optional configuration of the ATLAS Neurophysiology System that allows the patient to mark an event in the Data Acquisition Software.

NEURALYNX, INC.

Electrical-only medical device connection cable, reusable
Primary Device ID00850011306192
NIH Device Record Key93ed18ea-1597-40fe-b5b0-2c9b749e7ac8
Commercial Distribution StatusIn Commercial Distribution
Brand NameATLAS Patient Event Marker
Version Model NumberATLAS Patient Event Marker
Catalog NumberPatient Event Marker
Company DUNS933200842
Company NameNEURALYNX, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850011306192 [Primary]

FDA Product Code

IKDCable, Electrode

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-27
Device Publish Date2022-09-19

Devices Manufactured by NEURALYNX, INC.

00850011306932 - ATLAS Workstation Monitor2024-12-26 The ATLAS Workstation Monitor connects to the ATLAS Workstation (31-0004-0000).
00850011306949 - ATLAS Workstation2024-12-26 The ATLAS Workstation is a computer that runs the Data Acquisition Software.
00850011306956 - ATLAS Parallel TTL Cable2024-12-26 The Parallel TTL Cable is a ribbon cable that connects 25 pin computer parallel port to the digital I/O port on the ATLAS System
00850011306239 - ATLAS Rackmounted Power Isolator2024-12-19 An uninterruptible power supply that provides power to the ATLAS Neurophysiology System for up to five minutes and limits patien
00850011306253 - Ethernet Switch2024-12-19 The Ethernet Switch is a fully managed switch designed for high-performance networking in enterprise environments.
00850011306963 - Zipshield 5m2024-12-19 This product contains a full conductive metal plated cloth inner shield with a durable plastic outer jacket which is easily appl
00850011306970 - Zipshield 10m2024-12-19 This product contains a full conductive metal plated cloth inner shield with a durable plastic outer jacket which is easily appl
00850011306987 - ATLAS Power Isolator 110VAC2024-12-19 An uninterruptible power supply that provides power to the ATLAS Neurophysiology System for up to five minutes and limits patien

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.