AccessGUDID - DEVICE: Sejoy Oral Irrigator (06970392215433)

GUDID

Device Identifier (DI) Information

Brand Name: Sejoy Oral Irrigator
Version or Model: C11
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: JOYTECH HEALTHCARE CO.,LTD

Primary DI Number: 06970392215433
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544392778 *Terms of Use

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

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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFS	Unit, Oral Irrigation

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: 18916d86-bcca-4a85-ab3c-d2fe43a41144
Public Version Date: October 30, 2024
Public Version Number: 1
DI Record Publish Date: October 22, 2024