Catalog Number

-

Brand Name

EmboGold®

Version/Model Number

00884450100516

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

HCG

Product Code Name

DEVICE, NEUROVASCULAR EMBOLIZATION

Public Device Record Key

268c8487-0d19-406e-a27d-d1c622746ae7

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

October 31, 2015

Package DI Number

10884450100513

Quantity per Package

5

Contains DI Package

00884450100516

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-