Catalog Number

V2201CV

Brand Name

NOVAPLUS

Version/Model Number

V2201CV

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

November 13, 2023

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LYU

Product Code Name

ACCESSORY, SURGICAL APPAREL

Public Device Record Key

5dafda36-9f67-4f20-b47c-b829224e4282

Public Version Date

December 21, 2020

Public Version Number

3

DI Record Publish Date

September 26, 2018

Package DI Number

50885380114661

Quantity per Package

24

Contains DI Package

10885380114663

Package Discontinue Date

November 12, 2023

Package Status

In Commercial Distribution

Package Type

CASE