Catalog Number

71002-SC/MW/12

Brand Name

Mediwatch PlcNeurology Surface Electrodes

Version/Model Number

71002-SC/MW/12

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 05, 2021

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

9c9840e2-6771-4fb1-8ec4-2fa0e3c059fb

Public Version Date

October 06, 2021

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

05707480036868

Quantity per Package

80

Contains DI Package

05707480036875

Package Discontinue Date

October 05, 2021

Package Status

Not in Commercial Distribution

Package Type

-