Waterpik HairWand Pulse Spa System - Fix mount shower head and a hand held water comb - WATER PIK, INC.

Duns Number:001804074

Device Description: Fix mount shower head and a hand held water comb convenience kit, with PowerPulse and Easy Fix mount shower head and a hand held water comb convenience kit, with PowerPulse and EasySelect, chrome

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More Product Details

Catalog Number

YPW-833E/SPW-483MED

Brand Name

Waterpik HairWand Pulse Spa System

Version/Model Number

YPW-833E/SPW-483MED

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

LYG

Product Code Name

Massager, Therapeutic, Manual

Device Record Status

Public Device Record Key

ff932b7f-c9bc-4473-a1c5-6e984ff91696

Public Version Date

May 03, 2022

Public Version Number

2

DI Record Publish Date

July 13, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WATER PIK, INC." Characteristics
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