Catalog Number

GWI-1802-NS

Brand Name

Guidewire Introducer Needle Guidewire Access Needle

Version/Model Number

GWI-1802-NS

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

DWS

Product Code Name

INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Public Device Record Key

f41c1a56-10d7-4603-afa9-9d991d29f992

Public Version Date

October 02, 2020

Public Version Number

1

DI Record Publish Date

September 24, 2020

Package DI Number

10813079021930

Quantity per Package

8

Contains DI Package

00813079021933

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Carton