Catalog Number

22-60-730080

Brand Name

Grass EC3

Version/Model Number

Conductive Adhesive Gel

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

K852956

Product Code

GYB

Product Code Name

Media, Electroconductive

Public Device Record Key

a23ccfad-cd93-4f83-a1bc-d3226ae633bd

Public Version Date

March 26, 2019

Public Version Number

1

DI Record Publish Date

March 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-