Catalog Number

CB-1615

Brand Name

Cytology Brush

Version/Model Number

CB-1615

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 04, 2019

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

00621c57-bc31-4502-8561-2985877bb020

Public Version Date

November 05, 2019

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

10816207020539

Quantity per Package

10

Contains DI Package

00816207020532

Package Discontinue Date

November 04, 2019

Package Status

Not in Commercial Distribution

Package Type

box