LuM

Basic Information

• Brand Name: LuM
• Primary DI: 00813557020151
• Version / Model: LuM-3000
• Catalog Number: LUM-3000
• Company Name: Digital Doc LLC
• Labeler DUNS: 036787190
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-21
• Public Version: 1
• Public Version Date: 2025-01-29
• Public Version Status: New
• Public Device Record Key: 9ef2f73f-d6c2-4c9c-9ad5-7780cf9ff796

Device Description

LUM X80 & HD Sub Enamel illumination

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
EAZ	Light, Operating, Dental	Dental	872.4630	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56318	LED dental light, battery-powered	A battery-powered device designed for use in dentistry to project an intense and focused beam of light directly into or around the oral cavity of a patient via a light-emitting diode (LED), situated as the light head at the distal end of the device's light wand, to illuminate the site of a dental examination or procedure. The light head is connected to a light-intensity control unit, containing rechargeable batteries, via a flexible cable; for oral cavity illumination, the light wand may be attached to a suction cannula, a dental chair headrest, or to a retractor hooked on the patient's lower jaw. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813557020151	GS1