Catalog Number

-

Brand Name

ULTRATRACK Hybrid Guidewire 0.035" (0.89mm) x 150cm Regular Body, 3cm

Version/Model Number

GWH3505R

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"

-

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

95398908-c536-44aa-b9e3-5de1265e7190

Public Version Date

October 15, 2018

Public Version Number

1

DI Record Publish Date

September 13, 2018

Package DI Number

00821925031180

Quantity per Package

5

Contains DI Package

00821925031425

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-