Catalog Number

RBC-14-REV/A

Brand Name

ReSolve®, Revolution™

Version/Model Number

00884450414750

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)

-

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

K141408,K141408

Product Code

FGE

Product Code Name

Stents, drains and dilators for the biliary ducts

Public Device Record Key

fb4b008a-efc0-4dbb-b237-dd11f2eeb696

Public Version Date

May 03, 2021

Public Version Number

1

DI Record Publish Date

April 23, 2021

Package DI Number

10884450414757

Quantity per Package

5

Contains DI Package

00884450414750

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-