Catalog Number

011525

Brand Name

JETWIRE

Version/Model Number

011525-001

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

89b23d71-6246-4d58-9e15-21411e4241e2

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

February 27, 2015

Package DI Number

10616258005161

Quantity per Package

5

Contains DI Package

00616258005164

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Carton