Catalog Number

602-0108

Brand Name

Premium Study Kit

Version/Model Number

Large - Single

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

For Single-Use

Yes

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

K042039,K042039,K042039

Product Code

GWQ

Product Code Name

Full-Montage Standard Electroencephalograph

Public Device Record Key

d8d675d7-47bf-41c8-9098-e7d1fa49e1b9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

B14360201102

Quantity per Package

25

Contains DI Package

B14360201081

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box