Catalog Number

47597

Brand Name

NOVAPLUS

Version/Model Number

47597

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K823078,K823078,K823078

Product Code

FXX

Product Code Name

Mask, surgical

Public Device Record Key

5b4d9f30-d7d2-4d06-a3ac-1a6cd7cb16f5

Public Version Date

May 06, 2020

Public Version Number

2

DI Record Publish Date

May 16, 2019

Package DI Number

30680651475979

Quantity per Package

4

Contains DI Package

20680651475972

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS