Duns Number:352394143
Device Description: ISSA™ kids is a powered, silicone toothbrush with high-tech sonic power, a gentle non-rota ISSA™ kids is a powered, silicone toothbrush with high-tech sonic power, a gentle non-rotating brush head, anti-bacterial silicone bristles and 265 uses on a single USB charge, ISSA™ kids is all about perfecting your kid’s dental game. ISSA™ kids is intended for children 5 - 12 years old.
Catalog Number
-
Brand Name
ISSA™ kids
Version/Model Number
TRUE BLUE PONY
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
JEQ
Product Code Name
Toothbrush, Powered
Public Device Record Key
975cdd9d-fef9-4e37-8612-80c3799f5f67
Public Version Date
June 03, 2022
Public Version Number
1
DI Record Publish Date
May 26, 2022
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 63 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |