Duns Number:014578892
Device Description: Pro Clean Power Toothbrush with 2 RBH
Catalog Number
-
Brand Name
Rite Aid Pharmacy
Version/Model Number
SUF
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
09739d73-3f09-41ac-8e27-4f0de83e19be
Public Version Date
July 07, 2020
Public Version Number
2
DI Record Publish Date
June 26, 2020
Package DI Number
40011822934433
Quantity per Package
6
Contains DI Package
00011822934435
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 |