VistOR MS LED

GUDID 00816835023776

VistOR MS LED, DUO,SURGICAL LIGHT W/MONITOR ARM

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 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 Operating room light system

• Primary Device ID: 00816835023776
• NIH Device Record Key: 7f3144d8-fb31-4a27-878c-bef0da754fa9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VistOR MS LED
• Version Model Number: NVSD2M1-LCH
• Company DUNS: 093357739
• Company Name: Medical Illumination International Inc.
• Device Count: 1
• DM Exempt: true
• 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	00816835023776 [Primary]
GS1	01816835023775 [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: 2022-10-17
• Device Publish Date: 2022-10-07

On-Brand Devices [VistOR MS LED]

• 00816835021574: VistOR MS LED, TRIO, W/MON ARM WITH FIBRE OPTIC
• 00816835021567: VistOR MS LED, TRIO, W/MON ARM
• 00816835021550: VistOR MS LED, TRIO
• 00816835021543: VistOR MS LED, TRIO, HD CAMERA
• 00816835021536: VistOR MS LED, TRIO, W/MON ARM & HD CAM
• 00816835021529: VistOR MS LED, TRIO, W/MON ARM & HD CAM
• 00816835021512: VistOR MS LED, DUO, HD CAMERA
• 00816835021505: VistOR MS LED, DUO, W/MON ARM
• 00816835021499: VistOR MS LED, DUO
• 00816835021482: VistOR MS LED, SOLO
• 01816835023072: VistOR MS LED, SOLO, SURGICAL LIGHT
• 01816835023065: VistOR MS LED, TRIO, DUAL SURGICAL LIGHTS W/MONITOR ARM
• 01816835023058: VistOR MS LED, TRIO, DUAL SURGICAL LIGHTS, W/FO MONITOR ARM
• 01816835023041: VistOR MS LED,DUAL, SURGICAL LIGHTS
• 01816835023034: VistOR MS LED, SOLO, IL-CR SURGICAL LIGHT
• 01816835023027: VistOR MS LED, DUAL, IL-CR SURGICAL LIGHT & SURGICAL LIGHT
• 01816835022044: VistOR MS LED, SOLO, IL-CR, SURGICAL LIGHT
• 01816835023560: VistOR MS LED, QUAD, DUAL SURGICAL LIGHT, W/DUAL MONITOR ARMS
• 01816835023584: VistOR MS LED, QUAD, WITH 2 MON ARMS
• 01816835023577: VistOR MS LED, DUO, IL-CR SURG LIGHT & SURG LIGHT
• 00816835023776: VistOR MS LED, DUO,SURGICAL LIGHT W/MONITOR ARM