Catalog Number

-

Brand Name

Stradis Medical, LLC

Version/Model Number

IK

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)

-

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

537d0741-1a24-4208-96e4-872c28b629f6

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 28, 2019

Package DI Number

M752IK5

Quantity per Package

25

Contains DI Package

M752IK1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box