Catalog Number

-

Brand Name

STRADIS

Version/Model Number

689-405R1

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

OEQ

Product Code Name

Angiography/Angioplasty Kit

Public Device Record Key

7719b72a-8b3f-4692-9fb4-1abb1a34cf7f

Public Version Date

August 19, 2022

Public Version Number

1

DI Record Publish Date

August 11, 2022

Package DI Number

M752689405R11

Quantity per Package

5

Contains DI Package

M752689405R10

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-