ATLAS HD HEADBOX

Basic Information

• Brand Name: ATLAS HD HEADBOX
• Primary DI: 00850011306352
• Version / Model: ATLAS HD HEADBOX
• Catalog Number: 31-0601-0131
• Company Name: NEURALYNX, INC.
• Labeler DUNS: 933200842
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-05
• Public Version: 2
• Public Version Date: 2023-07-12
• Public Version Status: Update
• Public Device Record Key: 05104d3b-9060-4b64-beec-2ec5baf0e581

Device Description

The ATLAS HD Headbox is a clinical headbox that allows electrode connections ending in an MDR-68 connector to interface with the ATLAS Neurophysiology System. The ATLAS HD Headbox allows two MDR-68 connectors to be tied in parallel and a switch to disable active driven ground supplied by the ATLAS Neurophysiology system.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	882.1400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38736	Electroencephalographic monitoring system	An electrically-powered device assembly designed to continuously measure the electrical signals produced by a patient's brain and display/record them as an electroencephalogram (EEG) to evaluate brain function, typically in an examination room or intensive care unit (ICU) [bedside]; it may also monitor additional physiological parameters [e.g., electromyogram (EMG), respiration wave forms, blood pressure, haemoglobin oxygen saturation (SpO2)] in relation to EEG. It typically includes a control unit, electrodes, and components (e.g., amplifier, cables, probes). It may include data interpretation and/or telemetry features.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850011306352	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K110967	000