Vistor PRO LED

GUDID 00816835020423

MI-1000 Minor Surgical Light, Floor Stand

MEDICAL ILLUMINATION INTERNATIONAL INC.

Medical monitor/light stand Medical monitor/light stand Medical monitor/light stand Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Mobile examination/treatment room light Mobile examination/treatment room light Mobile examination/treatment room light Mobile examination/treatment room light Mobile examination/treatment room light Mobile examination/treatment room light Mobile examination/treatment room light Mobile examination/treatment room light Mobile examination/treatment room light Mobile examination/treatment room light Mobile examination/treatment room light Mobile examination/treatment room light Mobile examination/treatment room light Mobile examination/treatment room light Mobile examination/treatment room light Mobile examination/treatment room light Mobile examination/treatment room light Mobile examination/treatment room light

• Primary Device ID: 00816835020423
• NIH Device Record Key: 14860ea5-95a2-46e3-ab8f-e7f28190c4f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vistor PRO LED
• Version Model Number: NV061523
• 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	00816835020423 [Primary]
GS1	01816835020422 [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: 5
• Public Version Date: 2019-10-23
• 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