Catalog Number

S1010GH/C

Brand Name

Embosphere®

Version/Model Number

00884450403051

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

83210d46-0748-4a90-8678-6b5e3cec3747

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

December 02, 2019

Package DI Number

10884450403058

Quantity per Package

5

Contains DI Package

00884450403051

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-