AccessGUDID - DEVICE: Waterpik Sonic-Fusion 2.0 Professional (00073950318631)

GUDID

Device Identifier (DI) Information

Brand Name: Waterpik Sonic-Fusion 2.0 Professional
Version or Model: SF-04CD017-1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SF-04CD017-1
Company Name: WATER PIK, INC.

Primary DI Number: 00073950318631
Issuing Agency: GS1
Commercial Distribution End Date: April 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 001804074 *Terms of Use

Device Description: Water flosser integrated with a 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?
63584	Water jet flosser/sonic electric toothbrush	An electrically-powered device intended to provide a high-pressure water jet for dental flossing (removal of plaque and/or debris from between teeth) using a dedicated handpiece, and to provide (sonic) vibration for toothbrush heads attached to the handpiece for brushing the teeth. It is normally available [non-prescription] over-the-counter (OTC) fo use in the home or healthcare facility.	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: 34970519-14f1-4975-be19-205a65300ff2
Public Version Date: September 30, 2024
Public Version Number: 2
DI Record Publish Date: July 14, 2022