Catalog Number

79358

Brand Name

Halyard

Version/Model Number

79358

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

a42c3be7-3fa8-4878-af1c-0c2c2590aec9

Public Version Date

October 31, 2019

Public Version Number

1

DI Record Publish Date

October 23, 2019

Package DI Number

30680651793585

Quantity per Package

20

Contains DI Package

10680651793581

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS