Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

SS9335

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

KQM

Product Code Name

Camera, Surgical And Accessories

Public Device Record Key

8d81a4bb-4181-4235-bd6f-e0c9e3c9d328

Public Version Date

March 03, 2022

Public Version Number

2

DI Record Publish Date

June 29, 2018

Package DI Number

M752SS93355

Quantity per Package

25

Contains DI Package

M752SS93350

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box