Duns Number:014578892
Device Description: Power Toothbrush Oral Care Kit with pick and flosser
Catalog Number
-
Brand Name
Rite Aid Pharmacy
Version/Model Number
SUV
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)
-
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
f6b1c983-24ff-42b8-9189-20234f7adb9a
Public Version Date
January 08, 2021
Public Version Number
3
DI Record Publish Date
June 25, 2020
Package DI Number
40011822670348
Quantity per Package
6
Contains DI Package
00011822670340
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
inner
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |
| U | Unclassified | 2 |