Duns Number:006084093
Device Description: 0.4mL 5% Sodium Fluoride Varnish (Caramel) - 250 Units
Catalog Number
14203-250
Brand Name
NovaBright
Version/Model Number
14203-250
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
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
LBH
Product Code Name
VARNISH, CAVITY
Public Device Record Key
771bf8b3-3333-4382-809d-7f72069d6a5e
Public Version Date
March 25, 2020
Public Version Number
4
DI Record Publish Date
January 02, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 136 |