Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

IM1258

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

16ba5a1b-bb31-42eb-a236-0cf4b6546a29

Public Version Date

December 11, 2019

Public Version Number

2

DI Record Publish Date

November 29, 2018

Package DI Number

M752IM12585

Quantity per Package

50

Contains DI Package

M752IM12580

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box