Catalog Number

-

Brand Name

Single Use Biliary Balloon Dilator

Version/Model Number

BD-210N-0620

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

cd017a14-c0b3-462e-9e59-7c2e9bbc5c4b

Public Version Date

December 09, 2021

Public Version Number

5

DI Record Publish Date

September 05, 2017

Package DI Number

14953170400008

Quantity per Package

1

Contains DI Package

04953170400001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-