4F STIFF Micro-Stick® INTRODUCER SET WITH STAINLESS STEEL GUIDEWIRE - JET MEDICAL, INC.

Duns Number:079506014

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More Product Details

Catalog Number

JT090400001

Brand Name

4F STIFF Micro-Stick® INTRODUCER SET WITH STAINLESS STEEL GUIDEWIRE

Version/Model Number

JT090400001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

DYB

Product Code Name

Introducer, Catheter

Device Record Status

Public Device Record Key

2325b01d-2c49-4a92-a013-2b25783747d8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 20, 2015

Additional Identifiers

Package DI Number

30810988020157

Quantity per Package

5

Contains DI Package

00810988020156

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner box

"JET MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 63