LUMINANT

Basic Information

• Brand Name: LUMINANT
• Primary DI: 00049696736701
• Version / Model: 11012436DA
• Company Name: FOURSTAR GROUP INC.
• Labeler DUNS: 656091279
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-05
• Public Version: 1
• Public Version Date: 2023-02-13
• Public Version Status: New
• Public Device Record Key: f1ef23e0-53ff-442e-9547-7dcd1c8e8f44

Device Description

LUMINANT BO TB W/REMOVEABLE HD

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JEQ	Toothbrush, Powered	Dental	872.6865	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38581	Ionic electric toothbrush	A battery-powered instrument designed to brush clean the teeth and gums. It typically consists of a proximal handle and distal head to which is attached two or more rows of bristles (e.g., nylon) grouped in separate tufts, in rows, or evenly distributed; the head includes a light-activated semiconductor [e.g., a titanium (Ti) rod] that releases negative ions intended to disintegrate dental plaque. The device provides automated bristle movement (e.g., rotary or vibratory) intended to augment brushing and is used with toothpaste; it is normally available [non-prescription] over-the-counter (OTC). The toothbrush head may be exchangeable. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00049696736701	GS1