OroGenix Oral Hygiene Rinse

Basic Information

• Brand Name: OroGenix Oral Hygiene Rinse
• Primary DI: 00850015491153
• Version / Model: P-E1216T00
• Catalog Number: P-E1216T00
• Company Name: Sonoma Pharmaceuticals, Inc.
• Labeler DUNS: 081642964
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-02
• Public Version: 2
• Public Version Date: 2023-10-09
• Public Version Status: Update
• Public Device Record Key: 5681f7f9-f535-4bf1-a0ca-eda81c5cd5df

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KJJ	Cleanser, Root Canal	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
42345	Dental mouthwash	A substance intended to be used to clean and disinfect the oral cavity (including teeth and gums) for personal hygiene and/or dental clinical procedures. It is available in various forms (e.g., liquid solution, dissolving tablets) which inhibit bacterial growth and sometimes provide specific benefits for teeth (e.g., fluoride, whitening agents). It is intended for use in the home or a clinical setting. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20850015491157	GS1	Box	12	In Commercial Distribution
Primary	00850015491153	GS1

Device Sizes

Type	Value	Unit	Text
Total Volume	237	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 77 Degrees Fahrenheit