Catalog Number

-

Brand Name

MediMax Tech

Version/Model Number

SN90RT Snap Tens Electrode

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

Yes

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

-

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

2a365f0d-c907-4e10-b5d1-61c3cf40e70b

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

August 03, 2016

Package DI Number

30817325020672

Quantity per Package

5

Contains DI Package

20817325020675

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case