AccessGUDID - DEVICE: ATLAS-HS-36-CHET-D18 (00867718000292)

GUDID

Device Identifier (DI) Information

Brand Name: ATLAS-HS-36-CHET-D18
Version or Model: ATLAS-HS-36-CHET-D18
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 31-0601-0082
Company Name: NEURALYNX, INC.

Primary DI Number: 00867718000292
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 933200842 *Terms of Use

Device Description: The ATLAS-HS-36-CHET-D18 is a clinical headstage that allows two 18 contact DIXI electrode connectors to interface with the ATLAS Data Acquisition System. The ATLAS-HS-36-CHET-D18 uses electronic components to buffer single unit activity sensed by the electrodes and sends it to the ATLAS Data Acquisition System to be digitized.

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

FDA Product Code

[?]

Product Code	Product Code Name
GWL	Amplifier, Physiological Signal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 2f950c21-ce05-4c39-a3da-5f3008d6b317
Public Version Date: July 13, 2023
Public Version Number: 3
DI Record Publish Date: November 27, 2019