Catalog Number

989803105631

Brand Name

NA

Version/Model Number

CBL Reusable EEG Pedi Cup Electrodes

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

5019980c-0ac0-4c3a-a41f-e6dbca1bce78

Public Version Date

September 20, 2022

Public Version Number

7

DI Record Publish Date

April 18, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-