Catalog Number

ROWR3500ST

Brand Name

Rio Tracer - Hydrophilic Dual Flexible .035x150cm

Version/Model Number

ROWR3500ST

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"

Yes

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

EYA

Product Code Name

Stylet, Ureteral

Public Device Record Key

cbac2a1a-159d-4f79-9ec2-83dddfe3d246

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

October 11, 2016

Package DI Number

03700512985464

Quantity per Package

6

Contains DI Package

03700512975465

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box label 2