Catalog Number

WG010135RS

Brand Name

Steel Guide Wire with PTFE, Straight, .035x150cm, Removable Stylet

Version/Model Number

WG010135RS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 19, 2019

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

2f38e140-024b-46be-8f0f-34080f6a4d1e

Public Version Date

August 20, 2019

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

03700512985631

Quantity per Package

6

Contains DI Package

03700512975632

Package Discontinue Date

August 19, 2019

Package Status

Not in Commercial Distribution

Package Type

Box 2