Catalog Number

G2WSS35145NE

Brand Name

GO2WIRE™

Version/Model Number

00884450397442

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

cf6d4945-6027-4355-be3c-b359a8c6b50a

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

September 25, 2020

Package DI Number

10884450397449

Quantity per Package

3

Contains DI Package

00884450397442

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-