Catalog Number

V5795007

Brand Name

NOVAPLUS

Version/Model Number

V5795007

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

KGO

Product Code Name

Surgeon'S Gloves

Public Device Record Key

3ed4f6bc-d927-4cca-a92e-28691d1a30be

Public Version Date

March 14, 2022

Public Version Number

1

DI Record Publish Date

March 04, 2022

Package DI Number

20014566900906

Quantity per Package

50

Contains DI Package

10014566900909

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Dispenser