Catalog Number

DB-025, DB-050

Brand Name

NC-stat DPNCheck

Version/Model Number

NC-DP2

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

K041320,K041320,K041320

Product Code

JXE

Product Code Name

Device, Nerve Conduction Velocity Measurement

Public Device Record Key

0f877755-673a-4a86-8543-ad57af60a511

Public Version Date

October 22, 2018

Public Version Number

4

DI Record Publish Date

December 01, 2016

Package DI Number

20851221006081

Quantity per Package

50

Contains DI Package

00851221006087

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case