Catalog Number

90019

Brand Name

Halyard

Version/Model Number

90019

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

K842115,K842115

Product Code

KKX

Product Code Name

Drape, surgical

Public Device Record Key

70ca715b-af00-468a-a9d2-b89054db72c4

Public Version Date

November 01, 2021

Public Version Number

5

DI Record Publish Date

October 07, 2019

Package DI Number

30680651900198

Quantity per Package

34

Contains DI Package

10680651900194

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS