Duns Number:068331990
Device Description: Rexall Sonic Toothbrush Kids
Catalog Number
-
Brand Name
Rexall
Version/Model Number
25449901
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
June 24, 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
JEQ
Product Code Name
Toothbrush, Powered
Public Device Record Key
d5e35fa5-5927-4260-b41d-57fe98b5ca4e
Public Version Date
July 07, 2020
Public Version Number
2
DI Record Publish Date
June 24, 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 |