Waterpik Complete Care Oscillating 5.5 - Water flosser and oscillating toothbrush, black - WATER PIK, INC.

Duns Number:001804074

Device Description: Water flosser and oscillating toothbrush, black

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More Product Details

Catalog Number

WP-812W

Brand Name

Waterpik Complete Care Oscillating 5.5

Version/Model Number

WP-812W

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

EFS

Product Code Name

Unit, Oral Irrigation

Device Record Status

Public Device Record Key

da47e6fe-0663-4024-999a-acf638fdf4c9

Public Version Date

May 03, 2022

Public Version Number

2

DI Record Publish Date

July 01, 2020

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