Catalog Number

-

Brand Name

Gel-Block™ Embolization Pledgets

Version/Model Number

3630

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 31, 2017

Issuing Agency

In HIBCC

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)

Yes

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

88648f83-8026-45fe-b953-8145356f8eba

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

October 23, 2015

Package DI Number

M20636301

Quantity per Package

5

Contains DI Package

M20636300

Package Discontinue Date

May 31, 2017

Package Status

Not in Commercial Distribution

Package Type

-