Catalog Number

-

Brand Name

Single Use Biliary Balloon Dilator

Version/Model Number

BD-210N-0620

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 19, 2022

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

K143303,K143303

Product Code

FGE

Product Code Name

CATHETER, BILIARY, DIAGNOSTIC

Public Device Record Key

bfd9f6fa-8a30-44db-98dd-b2b8c76900c3

Public Version Date

August 22, 2022

Public Version Number

6

DI Record Publish Date

September 05, 2017

Package DI Number

14953170372299

Quantity per Package

1

Contains DI Package

04953170372292

Package Discontinue Date

August 19, 2022

Package Status

Not in Commercial Distribution

Package Type

-