Catalog Number

-

Brand Name

Endoscopic Cytology Brush

Version/Model Number

07-9001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 12, 2018

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K834402,K834402

Product Code

FDX

Product Code Name

Endoscopic Cytology Brush

Public Device Record Key

c5d5c2bf-36db-41eb-9c18-4c8243f7f5a7

Public Version Date

July 02, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

20874485002712

Quantity per Package

10

Contains DI Package

00874485003180

Package Discontinue Date

January 12, 2018

Package Status

Not in Commercial Distribution

Package Type

-