Catalog Number

G2WIJ35145NE

Brand Name

GO2WIRE™

Version/Model Number

00884450397367

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

b84d5f95-c112-411e-b96d-7028a80b6f80

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

July 31, 2020

Package DI Number

10884450397364

Quantity per Package

3

Contains DI Package

00884450397367

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-