Catalog Number

GWI-1802

Brand Name

Guidewire Introducer Needle

Version/Model Number

GWI-1802

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

bdb757e7-b585-4892-b73d-49ae9144991b

Public Version Date

October 02, 2020

Public Version Number

1

DI Record Publish Date

September 24, 2020

Package DI Number

20813079020305

Quantity per Package

10

Contains DI Package

10813079020308

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Carton