Catalog Number

V23503T

Brand Name

NOVAPLUS

Version/Model Number

V23503T

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

November 12, 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

FXO

Product Code Name

SUIT, SURGICAL

Public Device Record Key

3033f2d6-8eb3-4677-a3ea-d6ff8c61759d

Public Version Date

April 07, 2021

Public Version Number

3

DI Record Publish Date

June 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-