Catalog Number

89411

Brand Name

Halyard

Version/Model Number

89411

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

PUI

Product Code Name

Drape, surgical, exempt

Public Device Record Key

5455ee81-3707-45e8-b00f-839aa85f6dd5

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

February 02, 2017

Package DI Number

30680651894114

Quantity per Package

48

Contains DI Package

10680651894110

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS