Vu-E

GUDID 01816835023898

Vu-E, TRIO, SURGICAL LGHT W/MONITOR ARM

Medical Illumination International Inc.

Operating room light system

• Primary Device ID: 01816835023898
• NIH Device Record Key: 722c78d5-ba87-42f2-a296-d8219779bf90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vu-E
• Version Model Number: NVSD3D3M1-E-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	00816835023899 [Primary]
GS1	01816835023898 [Package]; Contains: 00816835023899; 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-04-10
• Device Publish Date: 2022-12-09

On-Brand Devices [Vu-E]

• 01816835023140: Vu-E, DUAL, SURGICAL LIGHT W/MONITOR ARM
• 01816835023133: Vu-E, SOLO, SURGICAL LIGHT
• 01816835023126: Vu-E, TRIO, SURGICAL LIGHTS, W/MONITOR ARM
• 01816835023119: Vu-E, DUAL, SURGICAL LIGHTS
• 01816835023102: Vu-E, SOLO, IL-CR SURGICAL LIGHT
• 01816835023096: Vu-E, TRIO,IL-CR SURGICAL LIGHT, SURGICAL LIGHT, W/MONITOR ARM
• 01816835023089: Vu-E, DUAL, IL-CR SURGICAL LIGHT & SURGICAL LIGHT
• 01816835023898: Vu-E, TRIO, SURGICAL LGHT W/MONITOR ARM