Catalog Number

-

Brand Name

Single Use Balloon Dilator V (with knife)

Version/Model Number

BD-VC431Q-1240-25

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"

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

K193039,K193039

Product Code

FGE

Product Code Name

Stents, drains and dilators for the biliary ducts

Public Device Record Key

ee88cc9a-d2a7-469d-b3be-df036409d49a

Public Version Date

December 17, 2021

Public Version Number

3

DI Record Publish Date

June 11, 2020

Package DI Number

14953170414104

Quantity per Package

1

Contains DI Package

04953170414107

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-