Catalog Number

-

Brand Name

VASCU-SHEATH®

Version/Model Number

TRAY #411

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 20, 2017

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

854b72a6-2bd9-4f7e-aa39-1cec60fe184f

Public Version Date

October 15, 2018

Public Version Number

4

DI Record Publish Date

April 29, 2016

Package DI Number

50884908024758

Quantity per Package

10

Contains DI Package

00884908024753

Package Discontinue Date

November 20, 2017

Package Status

Not in Commercial Distribution

Package Type

box