Catalog Number

GWP1406X

Brand Name

Porter

Version/Model Number

GWP1406X

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

DQX

Product Code Name

WIRE, GUIDE, CATHETER

Public Device Record Key

334517d9-576a-4640-ae58-863ed9b73d21

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

September 12, 2016

Package DI Number

10801741067652

Quantity per Package

5

Contains DI Package

00801741067655

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA