Catalog Number

-

Brand Name

Gel-Bead™ Embolization Spheres

Version/Model Number

3802

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

KRD

Product Code Name

Device, Vascular, For Promoting Embolization

Public Device Record Key

6cb232c6-96a2-4d19-87c6-ef5f2132f42f

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

October 23, 2015

Package DI Number

M20638021

Quantity per Package

5

Contains DI Package

M20638020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-