Nevadent

Basic Information

• Brand Name: Nevadent
• Primary DI: 16974637100017
• Version / Model: NMD 3.7 C8
• Company Name: Inwood Electronic Co., Ltd
• Labeler DUNS: 421175946
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-31
• Public Version: 1
• Public Version Date: 2023-04-10
• Public Version Status: New
• Public Device Record Key: 0a4c633b-1e76-4601-b41c-b7a6079c64ef

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
KAR	Irrigator, Sinus	Ear, Nose, Throat	874.4420	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	16974637100017	GS1