AccessGUDID - DEVICE: Waterpik Ultra and Cordless Plus Water Flosser (00073950256087)

GUDID

Device Identifier (DI) Information

Brand Name: Waterpik Ultra and Cordless Plus Water Flosser
Version or Model: WP-113W/WP-463W
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: WP-113W/WP-463W
Company Name: WATER PIK, INC.

Primary DI Number: 00073950256087
Issuing Agency: GS1
Commercial Distribution End Date: May 18, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 001804074 *Terms of Use

Device Description: Countertop and a rechargeable water flosser, blue

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:	Yes
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

FDA Product Code

[?]

Product Code	Product Code Name
EFS	Unit, Oral Irrigation

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: e3df3f26-7373-4009-b126-347dec6cefa8
Public Version Date: June 07, 2023
Public Version Number: 4
DI Record Publish Date: July 01, 2020