Catalog Number

-

Brand Name

STRADIS HEALTHCARE

Version/Model Number

695-097R1

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

OEZ

Product Code Name

Cardiovascular Procedure Kit

Public Device Record Key

1bfe862a-9784-46e3-846c-79003b078e72

Public Version Date

October 20, 2022

Public Version Number

1

DI Record Publish Date

October 12, 2022

Package DI Number

M752695097R11

Quantity per Package

10

Contains DI Package

M752695097R10

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-