Sejoy Oral Irrigator

Basic Information

• Brand Name: Sejoy Oral Irrigator
• Primary DI: 06970392215433
• Version / Model: C11
• Company Name: JOYTECH HEALTHCARE CO.,LTD
• Labeler DUNS: 544392778
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-22
• Public Version: 1
• Public Version Date: 2024-10-30
• Public Version Status: New
• Public Device Record Key: 18916d86-bcca-4a85-ab3c-d2fe43a41144

Device Description

A. The strong water pulse can deeply clean up the bacteria, Dental stains, tartar and food debris from you mouth. B. The superfine water pulse can deeply clean you slit between the teeth, improve your periodontal health. C. Deeply cleaning your tooth surface more than traditional dental floss. D. Deeply cleaning your oral cavity after eating, whatever at home or going out. It's your best choice to dental floss. E. Especiately it's good use for the corrected teeth, dental implants, dental cover surrounding. F. Help to build a healthy habit of cleaning oral cavity , keep it fresh and clean.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• 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
EFS	Unit, Oral Irrigation	Dental	872.6510	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06970392215433	GS1