Catalog Number

EVR50

Brand Name

Easi-Vue embolic microspheres System

Version/Model Number

Refill Syringe 50 micron

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K220567,K220567

Product Code

KRD

Product Code Name

Device, Vascular, For Promoting Embolization

Public Device Record Key

4ca4178c-c2e7-4027-9ea7-8eb517f13ede

Public Version Date

November 01, 2022

Public Version Number

1

DI Record Publish Date

October 24, 2022

Package DI Number

10850042341046

Quantity per Package

5

Contains DI Package

00850042341049

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton