Catalog Number

79135

Brand Name

Halyard

Version/Model Number

79135

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

60d54ba2-fe23-4c27-846c-294076adf64e

Public Version Date

August 05, 2019

Public Version Number

1

DI Record Publish Date

July 26, 2019

Package DI Number

30680651791352

Quantity per Package

30

Contains DI Package

10680651791358

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS