Duns Number:001804074
Device Description: Hand held shower head with DualDock and EasySelect, brushed nickel
Catalog Number
VOD-769ME
Brand Name
Waterpik PowerPulse with DualDock and EasySelect
Version/Model Number
VOD-769ME
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
LYG
Product Code Name
Massager, Therapeutic, Manual
Public Device Record Key
23399749-b876-41e5-a4e3-4df0b9b1edc1
Public Version Date
May 03, 2022
Public Version Number
2
DI Record Publish Date
November 02, 2021
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 |