Catalog Number

50696

Brand Name

Halyard

Version/Model Number

50696

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

FYC

Product Code Name

Gown, isolation, surgical

Public Device Record Key

ecfff93a-3199-4f74-afee-3e2cc1669d40

Public Version Date

September 08, 2020

Public Version Number

1

DI Record Publish Date

August 31, 2020

Package DI Number

30680651506963

Quantity per Package

10

Contains DI Package

20680651506966

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS