Catalog Number

-

Brand Name

Neuroguard

Version/Model Number

K50433-015

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

-

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

1345a3ec-712b-4aa6-ad5a-54500d75c494

Public Version Date

October 06, 2022

Public Version Number

1

DI Record Publish Date

September 28, 2022

Package DI Number

08720791370459

Quantity per Package

10

Contains DI Package

08720791370442

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf box