Duns Number:006309355
Device Description: Young Zooby 5% Sodium Fluoride White Varnish, 0.5mL each, Turtle Melon - Includes Bristle Young Zooby 5% Sodium Fluoride White Varnish, 0.5mL each, Turtle Melon - Includes Bristle Brush Applicator, 200 Strand Short Neck
Catalog Number
295713
Brand Name
Zooby
Version/Model Number
295713
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)
Yes
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
1d828a76-fa6c-48ca-8973-c5d5c3901cb7
Public Version Date
October 24, 2022
Public Version Number
1
DI Record Publish Date
October 16, 2022
Package DI Number
10302730002529
Quantity per Package
50
Contains DI Package
00302730002522
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 138 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85 |