Catalog Number

ROWP3500ST228

Brand Name

Hydrophilic Nitinol Guidewire Ø 0.035”, L. 150cm, standard, with 3cm straight fl

Version/Model Number

09-0008

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

e2fa419c-e204-4fdf-ba68-aeef41924693

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

November 13, 2017

Package DI Number

03700512986126

Quantity per Package

6

Contains DI Package

03700512976127

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box