1300XSB Xenon Light Source

GUDID 01816835024161

300 Watt Xenon Light Source, w/ Mobile Floor Stand

Medical Illumination International Inc.

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• Primary Device ID: 01816835024161
• NIH Device Record Key: a10910b5-4515-49e3-9a0b-9e37b153a4eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1300XSB Xenon Light Source
• Version Model Number: 02-1300XSB
• 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	00816835024162 [Primary]
GS1	01816835024161 [Package]; Contains: 00816835024162; Package: BOX [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022384

FDA Product Code

• HET: Laparoscope, Gynecologic (And Accessories)

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 [1300XSB Xenon Light Source]

• 01816835024178: 300 Watt Xenon Light Source, w/ Storage Box, Mobile Floor Stand
• 01816835024161: 300 Watt Xenon Light Source, w/ Mobile Floor Stand
• 01816835024154: 300 Watt Xenon Light Source, Portable