Catalog Number

ET1422

Brand Name

EndoTBrush Cytology Brush

Version/Model Number

ET1422

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"

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

-

Product Code

FDX

Product Code Name

Endoscopic Cytology Brush

Public Device Record Key

c6990898-23ee-42c5-8cd2-d8b5375a1336

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Package DI Number

10816207020157

Quantity per Package

10

Contains DI Package

00816207020150

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box