Catalog Number

41589

Brand Name

Kendall

Version/Model Number

41589

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)

Yes

Over the Counter (OTC)

-

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

3e1ef226-9c13-4a3f-8319-2a8f46f36852

Public Version Date

November 19, 2020

Public Version Number

3

DI Record Publish Date

June 30, 2018

Package DI Number

20884527018854

Quantity per Package

20

Contains DI Package

10884527018857

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE