Catalog Number

-

Brand Name

UroWire® Guidewire with SL-6® Hydrophilic Coating

Version/Model Number

B8634

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

EZB

Product Code Name

Stylet For Catheter, Gastro-Urology

Public Device Record Key

e76a4bb0-6e4b-49cd-aec5-af408e188d28

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 18, 2016

Package DI Number

10607915113855

Quantity per Package

6

Contains DI Package

00607915113858

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-