Catalog Number

S420GH/C

Brand Name

Embosphere®

Version/Model Number

00884450403426

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

e4668b78-269a-4df1-a8e2-4152bd11d46b

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

June 17, 2019

Package DI Number

10884450403423

Quantity per Package

5

Contains DI Package

00884450403426

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-