Catalog Number

A496166

Brand Name

PCI Kit/4 Percutaneous Catheter Introducer

Version/Model Number

A496166

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

K780126,K780126

Product Code

DRE

Product Code Name

Dilator, Vessel, For Percutaneous Catheterization

Public Device Record Key

b39e4591-17f1-4cc8-a04e-f00d64f40f45

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

September 12, 2016

Package DI Number

20886333216363

Quantity per Package

10

Contains DI Package

00886333216369

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box