Catalog Number

-

Brand Name

Ecogel 300

Version/Model Number

50TS

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

-

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

GYB

Product Code Name

Media, Electroconductive

Public Device Record Key

7e9c35b1-836b-429a-aaf2-2208e39d84c6

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

August 23, 2016

Package DI Number

00628055650690

Quantity per Package

4

Contains DI Package

00628055650539

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case