Catalog Number

-

Brand Name

STRADIS HEALTHCARE

Version/Model Number

570-2678

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 10, 2022

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

OEZ

Product Code Name

Cardiovascular Procedure Kit

Public Device Record Key

d8f6bfe2-6e8c-4617-bf21-1f9c2db14ffa

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

February 11, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-