Catalog Number

-

Brand Name

Carbon Rubber Electrode (4" cylinder)

Version/Model Number

0

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

K002227

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

edcd06f3-6e22-4bf7-b447-abb5d155ae4e

Public Version Date

July 23, 2021

Public Version Number

1

DI Record Publish Date

July 15, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-