Duns Number:248576691
Device Description: BriteBrush Brush Head Replacement 3-pack, composed of: 1 yellow brush head, 1 purple brush BriteBrush Brush Head Replacement 3-pack, composed of: 1 yellow brush head, 1 purple brush head, 1 blue brush head
Catalog Number
-
Brand Name
BriteBrush Brush Head Replacement 3-pack
Version/Model Number
1246
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
5660bec0-6921-4533-825a-82b2e98c4988
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 |