Catalog Number

ROWG3502ST228

Brand Name

Steel Guide Wire with PTFE Ø 0,035", L. 150cm, straight with removable stylet

Version/Model Number

09-0012

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

6cee405b-baa9-499e-830e-f0580b00264a

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

January 29, 2018

Package DI Number

03700512986164

Quantity per Package

60

Contains DI Package

03700512966166

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box2