Catalog Number

-

Brand Name

Single Use 3-Lumen Extraction Balloon V

Version/Model Number

B-V233P-A

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)

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

6105a1b2-bf6f-480f-bb7e-990c3acf3d41

Public Version Date

May 24, 2022

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

14953170368704

Quantity per Package

1

Contains DI Package

04953170368707

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-