Catalog Number

-

Brand Name

Halyard

Version/Model Number

89016

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

PUI

Product Code Name

Drape, Surgical, Exempt

Public Device Record Key

02902d24-c22e-4ca9-8f5e-a7e84768a9e9

Public Version Date

December 22, 2021

Public Version Number

7

DI Record Publish Date

December 04, 2015

Package DI Number

30680651890161

Quantity per Package

12

Contains DI Package

10680651890167

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-