Catalog Number

-

Brand Name

Single Use Combination Cleaning Brush

Version/Model Number

BW-411B

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

7dba005b-bda9-4a92-a9c2-12ba5aef1ff9

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 21, 2018

Package DI Number

54953170297415

Quantity per Package

4

Contains DI Package

04953170297410

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-