Catalog Number

DCNE-01-05X

Brand Name

FREMAP Electrode

Version/Model Number

DCNE-01-05X

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

Yes

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

K152769,K152769

Product Code

ETN

Product Code Name

STIMULATOR, NERVE

Public Device Record Key

6632dbc8-839a-49e7-9404-a8f210998ccb

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 03, 2016

Package DI Number

90841823108480

Quantity per Package

5

Contains DI Package

00841823108487

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-