Catalog Number

-

Brand Name

Stradis Medical, LLC

Version/Model Number

MM8515CP-2

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

-

Product Code Name

-

Public Device Record Key

63141a76-98fd-4c1b-88d8-2636384740c4

Public Version Date

June 12, 2019

Public Version Number

1

DI Record Publish Date

June 04, 2019

Package DI Number

M752MM8515CP25

Quantity per Package

24

Contains DI Package

M752MM8515CP20

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box