1300XSB-SP Xenon Light Source

GUDID 01816835024185

300 Watt Xenon Light Source, Single Port, Portable

Medical Illumination International Inc.

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• Primary Device ID: 01816835024185
• NIH Device Record Key: 8cfb55b7-0c92-45c4-a048-115039038bc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1300XSB-SP Xenon Light Source
• Version Model Number: 03-1300XSB-SP
• 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	00816835024186 [Primary]
GS1	01816835024185 [Package]; Contains: 00816835024186; 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-SP Xenon Light Source]

• 01816835024208: 300 Watt Xenon Light Source, Single Port, w/ Storage Box, Mobile Floor Stand
• 01816835024192: 300 Watt Xenon Light Source, Single Port, Mobile Floor Stand
• 01816835024185: 300 Watt Xenon Light Source, Single Port, Portable