Catalog Number

A395369

Brand Name

Guidewire

Version/Model Number

A395369

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

30f74493-55de-456c-a15f-6561de45d34b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 12, 2016

Package DI Number

10886333216250

Quantity per Package

10

Contains DI Package

00886333216253

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box