OptiLux LED Illuminator

Basic Information

• Brand Name: OptiLux LED Illuminator
• Primary DI: 00816835024247
• Version / Model: IL-2385 INTL
• Company Name: Medical Illumination International Inc.
• Labeler DUNS: 093357739
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-02
• Public Version: 1
• Public Version Date: 2023-10-10
• Public Version Status: New
• Public Device Record Key: 78d6814e-1f39-42ad-a441-926baf50bed3

Device Description

LED Illuminator, w/ Mobile Floor Stand, International

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
HBI	Illuminator, Fiberoptic, Surgical Field	General, Plastic Surgery	878.4580	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46113	Endoscopic light source adaptor	A device that provides an optical interface to match the light characteristics from an external light source (from a different endoscope manufacturer or model) to the fibreoptic bundles of an endoscope. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	01816835024246	GS1	BOX	1	In Commercial Distribution
Primary	00816835024247	GS1

Premarket Submissions

Submission Number	Supplement Number
K163185	000