Water Wise

Basic Information

• Brand Name: Water Wise
• Primary DI: 00840161304162
• Version / Model: 23Z100
• Company Name: ZIRC DENTAL PRODUCTS, INC.
• Labeler DUNS: 064783913
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-27
• Public Version: 2
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: 4643652f-ce8e-4b79-8d40-c3345cd730e2

Device Description

"Water Wise Starter Kit 1 x Bottle 1 x Adapter 1 x Lid 1 x Neon Blue Water Level Indicator (Bubbles) 1 x Yellow Water Level Indicator (Bubbles) 1 x Tube"

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NRD	Unit, Operative Dental, Accessories	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65032	Dental irrigation bottle	An empty plastic container, typically with a relatively narrow neck, intended to be filled with a fluid (e.g., distilled water) and connected to an irrigation unit for the irrigation of the oral cavity during a dental procedure; it is not intended for the storage of the fluid. It may be provided with a lid, tubing, connector(s), or non-powered valve(s); it does not include patient contact devices. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840161304162	GS1

Device Sizes

Type	Value	Unit	Text
Length	83	Millimeter
Width	83	Millimeter
Height	264	Millimeter