Catalog Number

-

Brand Name

BONASTENT® Tracheal/Bronchial

Version/Model Number

BTB-160305

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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"

-

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

K140472

Product Code

JCT

Product Code Name

Prosthesis, Tracheal, Expandable

Public Device Record Key

89a4042c-74c0-4e3c-851f-2a356ca99e6c

Public Version Date

October 25, 2021

Public Version Number

5

DI Record Publish Date

March 03, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-