Catalog Number

-

Brand Name

Visi-Pro

Version/Model Number

PXB35-07-27-135

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

P030045

Product Code

FGE

Product Code Name

Stents, drains and dilators for the biliary ducts

Public Device Record Key

86c4531a-6040-4299-89fb-a05152a53b99

Public Version Date

July 29, 2022

Public Version Number

4

DI Record Publish Date

September 09, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-