Catalog Number

RBC-8-038/C

Brand Name

ReSolve®

Version/Model Number

00884450313268

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

K141408,K141408

Product Code

FGE

Product Code Name

CATHETER, BILIARY, DIAGNOSTIC

Public Device Record Key

6bc272ce-5872-4313-aec2-db5d043dc655

Public Version Date

November 19, 2020

Public Version Number

4

DI Record Publish Date

October 16, 2017

Package DI Number

10884450313265

Quantity per Package

5

Contains DI Package

00884450313268

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-