Catalog Number

-

Brand Name

Super Brush

Version/Model Number

53-1195-DS

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KXG

Product Code Name

Applicator, Absorbent Tipped, Sterile

Public Device Record Key

eacaf76a-b95e-49e8-93cb-f80f45706038

Public Version Date

January 18, 2022

Public Version Number

3

DI Record Publish Date

December 31, 2021

Package DI Number

10603266531959

Quantity per Package

1500

Contains DI Package

00603266531952

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box