Vu160

GUDID 00816835024353

Vu160, DUO, SURGICAL LIGHT W/MONITOR ARM

Medical Illumination International Inc.

Operating room light

• Primary Device ID: 00816835024353
• NIH Device Record Key: 7c8ef0d2-4194-47d1-b4e5-f95266939cec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vu160
• Version Model Number: NVSD3M1-LCH
• 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	00816835024353 [Primary]
GS1	01816835024352 [Package]; Package: BOX [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100388

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: 2025-02-27
• Device Publish Date: 2025-02-19

On-Brand Devices [Vu160]

• 01816835024369: Vu160, TRIO, DUO SURGICAL LIGHTS W/MONITOR
• 00816835024353: Vu160, DUO, SURGICAL LIGHT W/MONITOR ARM