OptiLux LED Illuminator

GUDID 01816835024246

LED Illuminator, w/ Mobile Floor Stand, International

Medical Illumination International Inc.

Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source

• Primary Device ID: 01816835024246
• NIH Device Record Key: 78d6814e-1f39-42ad-a441-926baf50bed3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiLux LED Illuminator
• Version Model Number: IL-2385 INTL
• Company DUNS: 093357739
• Company Name: Medical Illumination International Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816835024247 [Primary]
GS1	01816835024246 [Package]; Contains: 00816835024247; Package: BOX [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163185

FDA Product Code

• HBI: Illuminator, Fiberoptic, Surgical Field

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-10
• Device Publish Date: 2023-10-02

On-Brand Devices [OptiLux LED Illuminator]

• 01816835024246: LED Illuminator, w/ Mobile Floor Stand, International
• 01816835024239: LED Illuminator, w/ Mobile Floor Stand, Domestic
• 01816835024222: LED Illuminator, Portable, International
• 01816835024215: LED Illuminator, Portable, Domestic