ATLAS HEADBOX 31-0601-0007

GUDID 00850011306048

The ATLAS Headbox is a clinical headbox that allows ECoG electrodes with 1.5mm Touch-Proof Connector Adapters to interface with the ATLAS Neurophysiology System.

NEURALYNX, INC.

Electroencephalographic monitoring system
Primary Device ID00850011306048
NIH Device Record Key6732f293-d1bb-422f-877d-2337b5f6570e
Commercial Distribution StatusIn Commercial Distribution
Brand NameATLAS HEADBOX
Version Model NumberATLAS HEADBOX
Catalog Number31-0601-0007
Company DUNS933200842
Company NameNEURALYNX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850011306048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OMCReduced- Montage Standard Electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-07-12
Device Publish Date2020-02-27

On-Brand Devices [ATLAS HEADBOX]

10850011306045The ATLAS Headbox is a clinical headbox that allows ECoG electrodes with 1.5mm Touch-Proof Conne
00850011306048The ATLAS Headbox is a clinical headbox that allows ECoG electrodes with 1.5mm Touch-Proof Conne

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