AccessGUDID - DEVICE: Waterpik Complete Care Sensonic (00073950314596)

GUDID

Device Identifier (DI) Information

Brand Name: Waterpik Complete Care Sensonic
Version or Model: CC-04W027-1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CC-04W027-1/TCC-030
Company Name: WATER PIK, INC.

Primary DI Number: 00073950314596
Issuing Agency: GS1
Commercial Distribution End Date: February 16, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 001804074 *Terms of Use

Device Description: Water flosser and sonic toothbrush, gray

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
12304	Oral lavage system	An assembly of devices intended for automated or semi-automated irrigation and washing of tissue/debris from teeth, gums, and other parts of the oral cavity (e.g., tongue) through application of pulsed jets of non-medicated liquids (e.g., mouthwash, water), to maintain oral hygiene; it may in addition be intended for nasal lavage. It consists of a central mains electricity (AC-powered) unit with a reservoir and pump, and a number of hand-held applicators, each typically designed to clean a specific oral anatomy (e.g., tongue, braces, gum line). It is normally available [non-prescription] over-the-counter (OTC) for use in the home and dental office.	Active	false
43090	Basic electric toothbrush	An electrically-powered device designed to be used by a patient to brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and an exchangeable distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device provides automated bristle movement (e.g., rotary or vibratory) intended to augment brushing, and is typically used with toothpaste. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFS	Unit, Oral Irrigation
JEQ	Toothbrush, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0cee572d-f231-4450-a985-5b4bbe54f420
Public Version Date: March 20, 2024
Public Version Number: 2
DI Record Publish Date: April 13, 2023