AccessGUDID - DEVICE: ATLAS NK HEADBOX (00850011306062)

GUDID

Device Identifier (DI) Information

Brand Name: ATLAS NK HEADBOX
Version or Model: ATLAS NK HEADBOX
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 31-0601-0017
Company Name: NEURALYNX, INC.

Primary DI Number: 00850011306062
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 933200842 *Terms of Use

Device Description: The ATLAS NK Headbox allows JE-125A, JE-225A, JE-226A, JE-227A, and JE-228A Mini Flat Junction Boxes by Nihon Kohden Corporation (NKC) to interface with the ATLAS Neurophysiology System by Neuralynx and JE-120A or JE-212A Amplifier by Nihon Kohden Corporation through the ATLAS NKSS Cable (also by Neuralynx).

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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OMC	Reduced- Montage Standard Electroencephalograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K110967	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: 011fd947-7d77-4f0d-b8b0-2c8fb5066d89
Public Version Date: July 12, 2023
Public Version Number: 2
DI Record Publish Date: February 27, 2020