Catalog Number

-

Brand Name

NeuMed

Version/Model Number

ELE-2020C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K081279,K081279

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

70d10101-fa59-4861-83ad-5a8ebddcc1b5

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

October 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-