Catalog Number

-

Brand Name

BONASTENT® Biliary

Version/Model Number

BB-080518

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

K140760

Product Code

FGE

Product Code Name

Catheter, Biliary, Diagnostic

Public Device Record Key

925fe631-6b4c-4686-b118-1955b89f3593

Public Version Date

April 08, 2022

Public Version Number

5

DI Record Publish Date

March 09, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-