Catalog Number

-

Brand Name

X-Series

Version/Model Number

02-4101

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K131383,K131383

Product Code

GWQ

Product Code Name

Full-Montage Standard Electroencephalograph

Public Device Record Key

8cb776da-ec4f-4ace-81dc-7a409099caf2

Public Version Date

January 11, 2022

Public Version Number

4

DI Record Publish Date

December 27, 2016

Package DI Number

10851113007366

Quantity per Package

5

Contains DI Package

00851113007369

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

kit of 5 headbands