Catalog Number

4040-SD

Brand Name

Medical Science Products

Version/Model Number

4040-SD

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

797e0213-1102-48ba-b490-13f98ea1718b

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

June 08, 2017

Package DI Number

10864666000326

Quantity per Package

120

Contains DI Package

00864666000329

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box