IsoLED II LED HL

GUDID 01816835023997

IsoLED II LED HL, w/ AC Power Pack

Medical Illumination International Inc.

Head-worn lamp

• Primary Device ID: 01816835023997
• NIH Device Record Key: d892e9aa-5e9b-4b90-8d66-b10a35ed862a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IsoLED II LED HL
• Version Model Number: IL-2317-02
• Company DUNS: 093357739
• Company Name: Medical Illumination International Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00816835023998 [Primary]
GS1	01816835023997 [Package]; Contains: 00816835023998; Package: BOX [1 Units]; In Commercial Distribution

FDA Product Code

• FCT: Headlight, Fiberoptic Focusing
• HPP: Headlamp, Operating, Battery-Operated

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 [IsoLED II LED HL]

• 01816835023997: IsoLED II LED HL, w/ AC Power Pack
• 01816835023980: IsoLED II LED HL, Standard