Catalog Number

G2WFS35175NE

Brand Name

GO2WIRE™

Version/Model Number

00884450397343

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DQX

Product Code Name

Wire, guide, catheter

Public Device Record Key

f18f70dd-4286-4e42-abca-2343ed49a66c

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

June 14, 2021

Package DI Number

10884450397340

Quantity per Package

3

Contains DI Package

00884450397343

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-