Catalog Number

-

Brand Name

Neurosign V4

Version/Model Number

4201-00

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 03, 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"

-

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

ETN

Product Code Name

Stimulator, Nerve

Public Device Record Key

aa42f62f-7674-4a02-b057-6d69e1c34b4e

Public Version Date

May 06, 2021

Public Version Number

3

DI Record Publish Date

June 28, 2017

Package DI Number

08718375864944

Quantity per Package

1

Contains DI Package

08718375865118

Package Discontinue Date

May 03, 2021

Package Status

Not in Commercial Distribution

Package Type

Pouch