Catalog Number

A035700

Brand Name

Standalone StruXure Guidewire

Version/Model Number

A035700

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"

Yes

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

K143135,K143135

Product Code

DQX

Product Code Name

WIRE, GUIDE, CATHETER

Public Device Record Key

15abd5ed-8648-4d12-95f2-3b149d801d10

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

10801741099356

Quantity per Package

10

Contains DI Package

00801741099359

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA