Duns Number:001804074
Device Description: Fix mount and hand held shower head convenience kit with One Touch, chrome
Catalog Number
XPA-133/763MVB
Brand Name
Waterpik PowerPulse 2in1 Shower System
Version/Model Number
XPA-133/763MVB
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
f4ba36c5-301c-4753-afee-b5bf1438535d
Public Version Date
May 03, 2022
Public Version Number
2
DI Record Publish Date
March 21, 2022
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 |