Catalog Number

-

Brand Name

Single Use Cytology Brush V

Version/Model Number

BC-V600P-3010

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

K902737,K902737

Product Code

FDX

Product Code Name

endoscopic cytology brush

Public Device Record Key

a9b7043e-908c-495a-812e-15185afc8c1c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

14953170285650

Quantity per Package

1

Contains DI Package

04953170285653

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-