Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

01-108

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

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

df25070c-19d8-4ce7-acf9-715c02f1784f

Public Version Date

December 11, 2019

Public Version Number

2

DI Record Publish Date

October 04, 2018

Package DI Number

M752011085

Quantity per Package

50

Contains DI Package

M752011080

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box