Catalog Number

-

Brand Name

NA

Version/Model Number

DS433/CSN2505

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)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K092546,K160138,K092546,K160138,K092546,K160138

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

9269bd2e-d5f7-423f-8a26-809e2410a651

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

October 12, 2016

Package DI Number

6970341674137

Quantity per Package

10

Contains DI Package

06970341670108

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

bag