Catalog Number

ET-5252

Brand Name

iReliev

Version/Model Number

ET-5252

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

3c772575-de13-4556-bbea-9896457fed8b

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

January 12, 2018

Package DI Number

10853635002461

Quantity per Package

500

Contains DI Package

00853635002464

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton