Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

01-109

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)

Yes

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

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

6ed3df62-48a9-4641-acba-62886d4b4c95

Public Version Date

December 11, 2019

Public Version Number

2

DI Record Publish Date

October 08, 2018

Package DI Number

M752011095

Quantity per Package

50

Contains DI Package

M752011090

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box