Vistor PRO LED

GUDID 00816835020294

MI-1000 Minor Surgical Light, Wall Mount

MEDICAL ILLUMINATION INTERNATIONAL INC.

Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system

• Primary Device ID: 00816835020294
• NIH Device Record Key: f232657c-351f-40f4-8215-e71a93d2ae11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vistor PRO LED
• Version Model Number: NV061512
• 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: false
• 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	00816835020294 [Primary]
GS1	01816835020293 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-12
• Device Publish Date: 2016-09-23

On-Brand Devices [Vistor PRO LED]

• 00816835020546: MI-1000 Minor Surgical Light, Floor Stand with Battery Back-up
• 00816835020454: MI-1000 Minor Surgical Light, Dual Ceiling
• 00816835020447: MI-1000 Minor Surgical Light, Single Ceiling
• 00816835020430: MI-1000 Minor Surgical Light, Wall Mount
• 00816835020423: MI-1000 Minor Surgical Light, Floor Stand
• 00816835020409: MI-1000 Minor Surgical Light, Floor Stand with Battery Back-up
• 00816835020317: MI-1000 Minor Surgical Light, Dual Ceiling
• 00816835020300: MI-1000 Minor Surgical Light, Single Ceiling
• 00816835020294: MI-1000 Minor Surgical Light, Wall Mount
• 01816835020286: MI-1000 Minor Surgical Light, Floor Stand