Catalog Number

5583700

Brand Name

J Guidewire

Version/Model Number

5583700

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

81bcc118-0991-455c-8005-55b868a90211

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 22, 2016

Package DI Number

20801741085448

Quantity per Package

4

Contains DI Package

10801741085441

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX