Catalog Number

-

Brand Name

EMSI 40X40 ELEC SMPL, 4/PCH

Version/Model Number

SRELEC0004

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 16, 2017

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K050788

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

2e709804-4347-4586-9d21-2ffdd11c4d07

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

May 16, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-