Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

1001NS

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)

-

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

MMP

Product Code Name

Cover, Barrier, Protective

Public Device Record Key

12038223-ddb1-4fe4-adad-ef067b496eac

Public Version Date

May 04, 2022

Public Version Number

1

DI Record Publish Date

April 26, 2022

Package DI Number

M7521001NS1

Quantity per Package

24

Contains DI Package

M7521001NS0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE