Duns Number:068331990
Device Description: Rexall Sonic Toothbrush Kids Brush Head 2pk
Catalog Number
-
Brand Name
Rexall
Version/Model Number
25458201
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
June 25, 2030
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EFW
Product Code Name
Toothbrush, Manual
Public Device Record Key
8ebe05a4-8b87-41e0-a7af-773b4396d66f
Public Version Date
July 07, 2020
Public Version Number
2
DI Record Publish Date
June 25, 2020
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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |
| U | Unclassified | 1 |