AccessGUDID - DEVICE: ATLAS Ground Drive (00850011306185)

GUDID

Device Identifier (DI) Information

Brand Name: ATLAS Ground Drive
Version or Model: Active Ground Drive
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 31-0604-0100
Company Name: NEURALYNX, INC.

Primary DI Number: 00850011306185
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 933200842 *Terms of Use

Device Description: The Active Ground Drive generates the Active Ground signal based on input selected in the Data Acquisition Software.

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
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: 27a3fba4-68da-492d-9d77-0e2b4bef4bf5
Public Version Date: November 12, 2024
Public Version Number: 2
DI Record Publish Date: September 19, 2022