Duns Number:062312574
Device Description: Power Toothbrush Kit
Catalog Number
-
Brand Name
CVS Health
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
EFW
Product Code Name
Toothbrush, Manual
Public Device Record Key
cca1e227-60b3-4982-9ab1-8ab5fc86d495
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
August 19, 2020
Package DI Number
40050428566747
Quantity per Package
6
Contains DI Package
00050428566749
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
inner/chip
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 82 |
2 | A medical device with a moderate to high risk that requires special controls. | 139 |
U | Unclassified | 23 |