AccessGUDID - DEVICE: Water Pik Revive with PowerPulse (10056310971209)

GUDID

Device Identifier (DI) Information

Brand Name: Water Pik Revive with PowerPulse
Version or Model: 20034197-120C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: URV-563M
Company Name: WATER PIK, INC.

Primary DI Number: 10056310971209
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 120
Labeler D-U-N-S® Number*: 001804074 *Terms of Use

Device Description: Handheld Pivoting Showerhead, Chrome Finish

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?
34661	External manual massager, home-use	A manual (non-powered) device specifically designed to apply external massage in the home. It is typically held in the hand of the user and drawn/rolled across the area of the body/muscles to be treated; it may also be designed to be placed on the floor for foot massage. The massaging components, e.g., roller heads or pads, may be interchangeable with others of different size and shape. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LYG	Massager, Therapeutic, Manual

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: 66a37f88-0418-41a2-ac83-34a18f25a5af
Public Version Date: April 17, 2025
Public Version Number: 1
DI Record Publish Date: April 09, 2025