Catalog Number

JT110183500

Brand Name

.018"(0.46MM) X 35CM ALLEVIO GUIDEWIRE

Version/Model Number

JT110183500

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 22, 2019

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

-

Product Code

KCJ

Product Code Name

Applicator, Ent

Public Device Record Key

5ca835af-91c1-4684-aa37-f1e9cfb9eb0f

Public Version Date

May 03, 2019

Public Version Number

4

DI Record Publish Date

July 20, 2015

Package DI Number

50810988020816

Quantity per Package

5

Contains DI Package

00810988020811

Package Discontinue Date

April 22, 2019

Package Status

Not in Commercial Distribution

Package Type

-