Catalog Number

-

Brand Name

Halyard

Version/Model Number

89421

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

KKX

Product Code Name

Drape, surgical

Public Device Record Key

b6445858-bc28-4671-8982-40bd31f66fad

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

December 04, 2015

Package DI Number

30680651894213

Quantity per Package

18

Contains DI Package

10680651894219

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-