Catalog Number

-

Brand Name

STRADIS

Version/Model Number

693-147

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FTN

Product Code Name

Kit, Plastic Surgery And Accessories

Public Device Record Key

1de2afeb-953f-4eee-a278-96b5dcf73d1c

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

August 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-