Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

20099SSHP

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"

Yes

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

PXC

Product Code Name

Personal Protection Kit

Public Device Record Key

5d203413-9ee0-4612-bb0d-116b3672fec1

Public Version Date

June 12, 2020

Public Version Number

1

DI Record Publish Date

June 04, 2020

Package DI Number

M75220099SSHP5

Quantity per Package

20

Contains DI Package

M75220099SSHP0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

OUTER BOX