Catalog Number

0515

Brand Name

Nikotab

Version/Model Number

0515

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

DRX

Product Code Name

Electrode, electrocardiograph

Public Device Record Key

d0e8caf6-3845-4212-a798-572aa9dc7914

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 03, 2017

Package DI Number

30853512006548

Quantity per Package

10

Contains DI Package

20853512006541

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cs