Catalog Number

9190

Brand Name

9000 Series Disposable Channel Cleaning Brush

Version/Model Number

9190

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

-

Product Code

MNL

Product Code Name

Accessories, Cleaning Brushes, For Endoscope

Public Device Record Key

c2f0b9de-0d21-438e-856a-4ce954ee5939

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

May 07, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-