OptiLux LED Illuminator

GUDID 01816835024222

LED Illuminator, Portable, International

Medical Illumination International Inc.

Endoscopic light source adaptor

• Primary Device ID: 01816835024222
• NIH Device Record Key: 5178a417-4e65-4bb4-8e3a-29c19f90b924
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiLux LED Illuminator
• Version Model Number: IL-2386 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	00816835024223 [Primary]
GS1	01816835024222 [Package]; Contains: 00816835024223; 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