Catalog Number

-

Brand Name

Neuroguard

Version/Model Number

K50431-002

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

617a268a-7bb4-44aa-a33a-9e694f3b50f9

Public Version Date

October 06, 2022

Public Version Number

1

DI Record Publish Date

September 28, 2022

Package DI Number

08720791370435

Quantity per Package

20

Contains DI Package

08720791370428

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf box