Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

20100SSOP

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

1e7ef553-32b5-4a11-af0d-1373b6c74935

Public Version Date

June 15, 2020

Public Version Number

1

DI Record Publish Date

June 05, 2020

Package DI Number

M75220100SSOP5

Quantity per Package

20

Contains DI Package

M75220100SSOP0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

OUTER BOX