Catalog Number

-

Brand Name

Stradis Medical, LLC

Version/Model Number

TSBRF-663

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

DRC

Product Code Name

Trocar

Public Device Record Key

31a00639-6dd9-424f-8d9d-ad87c9816a6d

Public Version Date

November 03, 2020

Public Version Number

1

DI Record Publish Date

October 26, 2020

Package DI Number

M752TSBRF6635

Quantity per Package

40

Contains DI Package

M752TSBRF6630

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box