Duns Number:783518983
Device Description: For use on:Skin VegetationsFatty GrainsFrecklesAge SpotsWartsVerrucaLarge MolesLarge Freck For use on:Skin VegetationsFatty GrainsFrecklesAge SpotsWartsVerrucaLarge MolesLarge Freckles
Catalog Number
-
Brand Name
Nuaskin Skin Tag Remover
Version/Model Number
FY-111
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"
-
For Single-Use
-
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
MIJ
Product Code Name
Needle, Tumor Localization
Public Device Record Key
de7e31a0-f6d0-4c78-bfaf-d9f5a0a4e984
Public Version Date
December 03, 2020
Public Version Number
1
DI Record Publish Date
November 25, 2020
Package DI Number
10860003125585
Quantity per Package
50
Contains DI Package
00860003125588
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Carton
| 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. | 44 |
| U | Unclassified | 11 |