Catalog Number

S420PRO

Brand Name

Embosphere Pro™

Version/Model Number

00884450299456

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

DEN160040

Product Code

NOY

Product Code Name

Agents, embolic, for treatment of benign prostatic hyperplasia

Public Device Record Key

afcb962f-5141-4172-99d4-89254ac53f55

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

December 18, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-