Catalog Number

-

Brand Name

HydroCel Geodesic Sensor Net

Version/Model Number

HCGSN 130

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 17, 2021

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

-

Product Code

GWQ

Product Code Name

Full-Montage Standard Electroencephalograph

Public Device Record Key

d7eac1d6-3c49-4a55-b95b-0d64886e8c91

Public Version Date

January 31, 2022

Public Version Number

3

DI Record Publish Date

October 04, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-