Duns Number:078444642
Device Description: Citrine 5% Sodium Fluoride Varnish, Bubble Gum Flavor - 50 x 0.4ml Unit-doses, 50 Applicat Citrine 5% Sodium Fluoride Varnish, Bubble Gum Flavor - 50 x 0.4ml Unit-doses, 50 Applicator Brushes, 1 Doctor Instruction Insert and 50 Patient Instruction Inserts
Catalog Number
56-00204
Brand Name
Citrine
Version/Model Number
56-00204
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
f412651e-506a-4d54-aab9-39e9256626a8
Public Version Date
February 07, 2019
Public Version Number
3
DI Record Publish Date
October 07, 2016
Package DI Number
10353045002360
Quantity per Package
12
Contains DI Package
00353045002363
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |