AccessGUDID - DEVICE: ATLAS Headbox Expansion Panel (00850011306512)

GUDID

Device Identifier (DI) Information

Brand Name: ATLAS Headbox Expansion Panel
Version or Model: ATLAS HEP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 31-0607-0014
Company Name: NEURALYNX, INC.

Primary DI Number: 00850011306512
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 933200842 *Terms of Use

Device Description: The ATLAS Headbox Expansion Panel is an accessory to the ATLAS Neurophysiology System and ATLAS Stim Headbox. The HEP is a power module and a signal splitter.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36740	Electroencephalographic signal amplifier	An electrical device intended to amplify the signal level and to provide impedance matching between two or more medical devices when bioelectrical signals from the brain are transmitted between them.	Active	false
35726	Somatosensory electrical stimulation system	An assembly of devices used to apply precisely timed and repeatable electrical stimuli to the peripheral nerves, typically for evoked potential and other research procedures (e.g., functional mapping in epilepsy). It is usually a multichannel external stimulation system, consisting of external surface electrodes or invasive (i.e., needle) electrodes, and a pulse generator. It may be used as a component of more complex devices such as somatosensory evoked-potential recording systems.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GYC	Electrode, Cortical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K110967	000
K250094	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 747bbe12-8672-4023-bbf7-447fcf8f3e2f
Public Version Date: June 10, 2025
Public Version Number: 3
DI Record Publish Date: November 10, 2022