iZoom Loupes

Basic Information

• Brand Name: iZoom Loupes
• Primary DI: 00860179001099
• Version / Model: 8500051
• Catalog Number: 8500051
• Company Name: Dentlight Inc.
• Labeler DUNS: 171208585
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-09
• Public Version: 2
• Public Version Date: 2022-01-25
• Public Version Status: Update
• Public Device Record Key: 5ba90af6-3bfe-4631-b957-69690b715bd9

Device Description

iZoom Magnification Loupes

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
FSP	Loupe, Diagnostic/Surgical	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15652	Loupe	A convex lens with an built-in, electrical light source used for magnifying vision and concentrating the light upon an object or objects being viewed. It can be used for a variety of purposes, e.g., the examination of an object for laboratory work, diagnosis, minor surgery, dermatology, or by persons with a strong eyesight impairment. The loupe is typically mounted on the end of an adjustable arm (e.g., a flexible tube or an articulating arm) which is attached to a stable base or clamped to a surface worktop.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860179001099	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]