IsoLED II LED HL (AC)

GUDID 01816835024000

IsoLED II LED HL, w/ AC Unit

Medical Illumination International Inc.

Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp

• Primary Device ID: 01816835024000
• NIH Device Record Key: 7b6683e3-dbb6-49e2-8f4d-e378569a57cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IsoLED II LED HL (AC)
• Version Model Number: IL-2318
• 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	00816835024001 [Primary]
GS1	01816835024000 [Package]; Contains: 00816835024001; Package: BOX [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102266

FDA Product Code

• FST: Light, Surgical, Fiberoptic

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

Devices Manufactured by Medical Illumination International Inc.

• 01816835023898 - Vu-E: 2024-04-10 Vu-E, TRIO, SURGICAL LGHT W/MONITOR ARM
• 01816835024314 - SYSTEM TWO LED: 2024-01-26 SYSTEM TWO LED, TRIO, IL-CR & DUO SURGICAL LIGHT
• 01816835024307 - SYSTEM TWO LED: 2024-01-10 SYSTEM TWO LED, DUO,IL-CR SURG LIGHT W/MON ARM
• 00816835023950 - IsoLED Mini LED HL: 2023-10-10 IsoLED mini LEDHL, Standard, w/Mounting Clips
• 01816835023966 - IsoLED Mini LED HL: 2023-10-10 IsoLED mini LEDHL, Attached to Safety Glasses
• 01816835023973 - IsoLED Mini LED HL: 2023-10-10 IsoLED mini LEDHL, Attached to Headgear
• 01816835023980 - IsoLED II LED HL: 2023-10-10 IsoLED II LED HL, Standard
• 01816835023997 - IsoLED II LED HL: 2023-10-10 IsoLED II LED HL, w/ AC Power Pack