Duns Number:057728685
Device Description: Sparkle V Sodium Fluoride Varnish Bubble Gum
Catalog Number
UFVBG
Brand Name
Crosstex International
Version/Model Number
UFVBG
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
95fa54c9-dffb-4c55-a6b9-0bbe4fc6c20b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 11, 2016
Package DI Number
50732224000324
Quantity per Package
5
Contains DI Package
10732224000326
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 33 |
2 | A medical device with a moderate to high risk that requires special controls. | 25 |