Catalog Number

-

Brand Name

Reducing Diameter Tracheal Stent with Posts

Version/Model Number

RTP-12-8-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

d29f5e94-ae08-42ba-be9b-b54157479b48

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

-