Duns Number:248576691
Device Description: BriteBrush Sesame Street, composed of: 1 assembled brush (w/ Sesame Street handle and red BriteBrush Sesame Street, composed of: 1 assembled brush (w/ Sesame Street handle and red brush head), 1 extra brush head (blue)
Catalog Number
-
Brand Name
BriteBrush™ Sesame Street™
Version/Model Number
1229
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 14, 2021
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)
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
5b041179-d87c-41ed-b1de-ca682fbde4c9
Public Version Date
December 22, 2021
Public Version Number
1
DI Record Publish Date
December 14, 2021
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 | 4 |