Catalog Number

-

Brand Name

BODYMED

Version/Model Number

NPP933R

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

K170744,K170744

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

a8da86d3-1e26-41a7-bc8f-959ae554d450

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

April 13, 2018

Package DI Number

20815991021675

Quantity per Package

560

Contains DI Package

00815991021671

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON