VistOR MS LED

GUDID 01816835023058

VistOR MS LED, TRIO, DUAL SURGICAL LIGHTS, W/FO MONITOR ARM

MEDICAL ILLUMINATION INTERNATIONAL INC.

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• Primary Device ID: 01816835023058
• NIH Device Record Key: eb1e0769-00dc-497c-9687-9a434b870b8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VistOR MS LED
• Version Model Number: NVSD2D2M1-FO-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	00816835023059 [Primary]
GS1	01816835023058 [Package]; Contains: 00816835023059; 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: 2020-03-24
• Device Publish Date: 2020-03-16

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