Catalog Number

-

Brand Name

NeuroMatrix

Version/Model Number

CNC5025

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

K012814

Product Code

JXI

Product Code Name

Cuff, Nerve

Public Device Record Key

b9a42cd7-4c03-4d8e-8c2f-b3a72589712c

Public Version Date

December 08, 2021

Public Version Number

4

DI Record Publish Date

September 16, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-