Catalog Number

S020GH/A

Brand Name

Embosphere®

Version/Model Number

00884450299432

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

NAJ

Product Code Name

Agents, embolic, for treatment of uterine fibroids

Public Device Record Key

97d05b51-4d2f-45c9-af20-3e3e45fa84cf

Public Version Date

September 28, 2022

Public Version Number

1

DI Record Publish Date

September 20, 2022

Package DI Number

10884450299439

Quantity per Package

5

Contains DI Package

00884450299432

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-