Catalog Number

72015-K/C/12

Brand Name

Neuroline 720Neurology Surface Electrodes

Version/Model Number

72015-K/C/12

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

a2d2fca2-03c7-48e1-a4e4-8a2a1784a96e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Package DI Number

05707480029198

Quantity per Package

40

Contains DI Package

05707480029204

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-