Duns Number:054326178
Device Description: Toothbrush with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse
Catalog Number
6301
Brand Name
Sage Self Oral Care
Version/Model Number
6301
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
Yes
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
31ff37d4-7e89-46d0-837c-9eebc0ec65ed
Public Version Date
September 21, 2020
Public Version Number
1
DI Record Publish Date
September 11, 2020
Package DI Number
50618029831229
Quantity per Package
48
Contains DI Package
00618029831224
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 64 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |