Catalog Number

ET-1313

Brand Name

iReliev

Version/Model Number

ET-1313

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

K091757,K091757

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

95319fad-9c5c-49a5-bae1-0f1e3c59c475

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

June 27, 2016

Package DI Number

10853635002034

Quantity per Package

40

Contains DI Package

00853635002037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton