Catalog Number

-

Brand Name

DISPOSABLE CYTOLOGY BRUSH

Version/Model Number

BC-17W

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 23, 2022

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

K904799,K904799

Product Code

FBN

Product Code Name

Choledochoscope and accessories, flexible/rigid

Public Device Record Key

1227ce6e-f222-4bcc-807c-0ab9ff085dad

Public Version Date

June 24, 2022

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

14953170042789

Quantity per Package

6

Contains DI Package

04953170042782

Package Discontinue Date

June 23, 2022

Package Status

Not in Commercial Distribution

Package Type

-