Catalog Number

490008

Brand Name

Long Sheath Introducer

Version/Model Number

490008

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

K891022,K891022

Product Code

DYB

Product Code Name

Introducer, Catheter

Public Device Record Key

e7f67bab-a3fe-4f59-ac28-471fc290d2eb

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

20886333213034

Quantity per Package

10

Contains DI Package

00886333213030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box