Catalog Number

120010-14

Brand Name

ConvertX™ Nephroureteral Stent System

Version/Model Number

10.3F x 14cm

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 07, 2021

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

-

Product Code

FAD

Product Code Name

Stent, Ureteral

Public Device Record Key

fc4a9069-7e7d-486a-a4a8-85b963e5de31

Public Version Date

June 08, 2021

Public Version Number

3

DI Record Publish Date

November 08, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-