Catalog Number

-

Brand Name

DISPOSABLE CYTOLOGY BRUSH

Version/Model Number

BC-202D-1210

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

K931154,K931154

Product Code

EOQ

Product Code Name

BRONCHOSCOPE (FLEXIBLE OR RIGID)

Public Device Record Key

341e0bc6-a652-4819-9b34-9a6d082dd6b4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

14953170049344

Quantity per Package

10

Contains DI Package

04953170049347

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-