Catalog Number

-

Brand Name

VSI Radial™ introducer sheath

Version/Model Number

9008

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 2019

Issuing Agency

In HIBCC

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

-

Product Code

DYB

Product Code Name

Introducer, Catheter

Public Device Record Key

d640af78-ad19-496e-88b1-453fc4a6e9fa

Public Version Date

July 23, 2019

Public Version Number

4

DI Record Publish Date

September 05, 2016

Package DI Number

M20690081

Quantity per Package

5

Contains DI Package

M20690080

Package Discontinue Date

June 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Box