Duns Number:001804074
Device Description: Water flosser and sonic toothbrush, white
Catalog Number
CC-01CD010-1
Brand Name
Waterpik Complete Care Sonic 9.0
Version/Model Number
CC-01CD010-1
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EFS
Product Code Name
Unit, Oral Irrigation
Public Device Record Key
972022a2-9443-43be-8488-4baf8c5c4555
Public Version Date
May 03, 2022
Public Version Number
2
DI Record Publish Date
July 01, 2020
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 | 293 |
2 | A medical device with a moderate to high risk that requires special controls. | 56 |