Catalog Number

ROWR3501ST

Brand Name

NaviBluTM Angled/Straight Dual Flexible:Nitinol Wire Hydrophilic Tips 0.035inch

Version/Model Number

09-0006

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

21f2a8d7-d45e-418f-9bc4-b561f8877b9a

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

November 09, 2017

Package DI Number

03700512986102

Quantity per Package

6

Contains DI Package

03700512976103

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box