Catalog Number

RCX12-8-038

Brand Name

ReSolve ConvertX®

Version/Model Number

00884450452868

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)

-

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

1d741713-bfcc-46ed-8f95-1780852f21fd

Public Version Date

October 11, 2021

Public Version Number

2

DI Record Publish Date

January 28, 2020

Package DI Number

10884450452865

Quantity per Package

1

Contains DI Package

00884450452868

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-