Catalog Number

-

Brand Name

STRADIS HEALTHCARE

Version/Model Number

890-005

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

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

MHW

Product Code Name

Dressing, Compression

Public Device Record Key

ffb52b5a-506d-47ec-814f-6ec72bc28ac5

Public Version Date

May 09, 2022

Public Version Number

1

DI Record Publish Date

April 29, 2022

Package DI Number

M7528900051

Quantity per Package

5

Contains DI Package

M7528900050

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE