Duns Number:001804074
Device Description: Fix mount and hand held shower head convenience kit, black
Catalog Number
XPB-135E/765ME
Brand Name
Waterpik PowerPulse
Version/Model Number
XPB-135E/765ME
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
951854ac-a73f-4517-a936-bd0702a93d74
Public Version Date
August 02, 2022
Public Version Number
1
DI Record Publish Date
July 25, 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 |