Sejoy Oral Irrigator

Primary DI
06970392215433
Brand
Sejoy Oral Irrigator
Company
JOYTECH HEALTHCARE CO.,LTD
Model
C11
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.
Published
2024-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
EFSUnit, Oral Irrigation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFSUnit, Oral IrrigationDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970392215433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970392215433069703922154336970392215433

GMDN Terms#

Term, Definition table
TermDefinition
Oral lavage systemAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544392778
Device count
1
Premarket exempt
true
Manufacturing date on label
true

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