Catalog Number

-

Brand Name

Mothermed

Version/Model Number

EP408

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)

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

10a2bb7d-b09c-4ef5-8cf5-ab97fd8f8a10

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

July 07, 2017

Package DI Number

10818218029037

Quantity per Package

80

Contains DI Package

00818218029030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX