Catalog Number

-

Brand Name

Cleaning Brush To Be Used In Any Endoscope With a 3 Fr (1 mm) Channel

Version/Model Number

CB-365

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"

-

For Single-Use

-

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

f8c68b01-1bd5-49ba-ac8f-58c9d390913a

Public Version Date

October 15, 2018

Public Version Number

1

DI Record Publish Date

September 13, 2018

Package DI Number

00821925008762

Quantity per Package

2

Contains DI Package

00821925038295

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-