Catalog Number

-

Brand Name

VASCU-SHEATH®II

Version/Model Number

MCVSI11

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"

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

ad190aeb-383b-46d5-ab58-f54d5f39bfc1

Public Version Date

October 15, 2018

Public Version Number

4

DI Record Publish Date

September 02, 2016

Package DI Number

30884908027380

Quantity per Package

20

Contains DI Package

00884908027389

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner box