Catalog Number

EC5025

Brand Name

EmboCube™

Version/Model Number

00884450306222

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KRD

Product Code Name

Device, Vascular, for Promoting Embolization

Public Device Record Key

912b4835-cab0-4c19-8696-1eb03095e589

Public Version Date

October 11, 2021

Public Version Number

3

DI Record Publish Date

March 23, 2019

Package DI Number

10884450306229

Quantity per Package

5

Contains DI Package

00884450306222

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-