Catalog Number

V20685785

Brand Name

NOVAPLUS

Version/Model Number

V20685785

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"

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

KGO

Product Code Name

Surgeon'S Gloves

Public Device Record Key

aad9d968-ac8a-4ba8-9e99-98d664cb00bc

Public Version Date

March 18, 2022

Public Version Number

1

DI Record Publish Date

March 10, 2022

Package DI Number

20014566300850

Quantity per Package

50

Contains DI Package

10014566300853

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Dispenser