Catalog Number

JT070500001

Brand Name

5F REGULAR Micro-Stick® INTRODUCER SET WITH STAINLESS STEEL GUIDEWIRE

Version/Model Number

JT070500001

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

-

Product Code

DYB

Product Code Name

Introducer, Catheter

Public Device Record Key

72fd1819-460c-4073-9a46-06df40bfcc85

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 20, 2015

Package DI Number

30810988020126

Quantity per Package

5

Contains DI Package

00810988020125

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner box