Catalog Number

-

Brand Name

Single Use 3-Lumen Extraction Balloon V

Version/Model Number

B-V243Q-A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 12, 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)

Yes

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

-

Product Code

FGE

Product Code Name

CATHETER, BILIARY, DIAGNOSTIC

Public Device Record Key

df424ceb-4964-4c5d-982a-e5d617366e73

Public Version Date

August 15, 2022

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

14953170279512

Quantity per Package

1

Contains DI Package

04953170279515

Package Discontinue Date

August 12, 2022

Package Status

Not in Commercial Distribution

Package Type

-