Duns Number:001804074
Device Description: Countertop water flosser, stain removing tablets inserted into flosser handle, white
Catalog Number
WF-05CD020
Brand Name
Waterpik Whitening Professional Water Flosser
Version/Model Number
WF-05CD020
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
d5061290-cb93-4c1b-898d-0d2189f3afe7
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 |