Catalog Number

-

Brand Name

Straight Stoma Stent

Version/Model Number

SS-1540

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K882430

Product Code

BTO

Product Code Name

Tube, Tracheostomy (W/Wo Connector)

Public Device Record Key

01b6c998-cc0c-40b9-bb17-802666ae2b79

Public Version Date

June 05, 2020

Public Version Number

4

DI Record Publish Date

April 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-