Catalog Number

-

Brand Name

Stradis Medical, LLC

Version/Model Number

MM8515CP-1

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

697ae0c6-a297-4b8a-80c4-25da5d54c69f

Public Version Date

October 08, 2018

Public Version Number

1

DI Record Publish Date

September 05, 2018

Package DI Number

M752MM8515CP15

Quantity per Package

24

Contains DI Package

M752MM8515CP10

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box