Catalog Number

-

Brand Name

Stradis Healthcare

Version/Model Number

690-388

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 24, 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"

-

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

bb89ffd4-3eac-41b0-9716-2258fef7f35b

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

May 16, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-