Catalog Number

8021

Brand Name

NovaPlus

Version/Model Number

8021

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

August 27, 2025

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"

Yes

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

FMK

Product Code Name

Lancet, Blood

Public Device Record Key

c27a13a9-6228-4c7c-b6fb-eb2b6e677b53

Public Version Date

September 04, 2020

Public Version Number

1

DI Record Publish Date

August 27, 2020

Package DI Number

00732671080219

Quantity per Package

100

Contains DI Package

10732671180213

Package Discontinue Date

August 27, 2025

Package Status

In Commercial Distribution

Package Type

Chipboard Carton