Catalog Number

2120B/BT

Brand Name

Trackit

Version/Model Number

Trackit 20/4/B Kit

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

K010460

Product Code

GWQ

Product Code Name

Full-Montage Standard Electroencephalograph

Public Device Record Key

bdfbea6f-a545-4556-aee3-8f3a69e91372

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

September 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-