Catalog Number

-

Brand Name

Neurosign V4

Version/Model Number

1705-01

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

GXZ

Product Code Name

Electrode, Needle

Public Device Record Key

d8c33bb7-7930-4ce2-9f58-38f06ec6c252

Public Version Date

January 20, 2021

Public Version Number

1

DI Record Publish Date

January 12, 2021

Package DI Number

08718375867976

Quantity per Package

20

Contains DI Package

08718375867969

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelfbox