Catalog Number

70020-K/C/4

Brand Name

Neuroline 700Neurology Surface Electrodes

Version/Model Number

70020-K/C/4

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

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

-

Product Code

GXY

Product Code Name

ELECTRODE, CUTANEOUS

Public Device Record Key

bc4712c7-b12f-463d-822a-7c1b7fd012f3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Package DI Number

05707480021116

Quantity per Package

2

Contains DI Package

05707480028702

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-