Duns Number:081057389
Device Description: Novaplus ASTM Fluid-Rated Fog-Free Surgical Mask, Aqua
Catalog Number
47587
Brand Name
NOVAPLUS
Version/Model Number
47587
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
-
Product Code
FXX
Product Code Name
Mask, surgical
Public Device Record Key
42d7cc90-ef1a-40bb-b0ff-f42c27b317ef
Public Version Date
May 06, 2020
Public Version Number
2
DI Record Publish Date
May 16, 2019
Package DI Number
30680651475870
Quantity per Package
6
Contains DI Package
20680651475873
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1044 |