Catalog Number

WH0022-01

Brand Name

Halyard

Version/Model Number

WH0022-01_0002

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

ITG

Product Code Name

BANDAGE, CAST

Public Device Record Key

2d1f842a-fb6d-4590-a095-828d0ffa24c2

Public Version Date

August 08, 2022

Public Version Number

1

DI Record Publish Date

July 29, 2022

Package DI Number

20809160378899

Quantity per Package

5

Contains DI Package

10809160378892

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-