Catalog Number

41533

Brand Name

Kendall

Version/Model Number

41533

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GEC

Product Code Name

BRUSH, SCRUB, OPERATING-ROOM

Public Device Record Key

c03abee8-07af-4c4a-bb31-0fcbe988af63

Public Version Date

November 19, 2020

Public Version Number

3

DI Record Publish Date

June 30, 2018

Package DI Number

30884527018721

Quantity per Package

20

Contains DI Package

20884527018724

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE