Catalog Number

-

Brand Name

Tracheal Stent with Rings

Version/Model Number

TS-1280-S

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

K873742

Product Code

NWA

Product Code Name

Prosthesis, Tracheal, Preformed/Molded

Public Device Record Key

9fb45a51-23d0-4497-a6a2-06b0ecad81af

Public Version Date

June 05, 2020

Public Version Number

4

DI Record Publish Date

December 21, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-