VISERA ELITE II VIDEO SYSTEM CENTER

GUDID 04953170386060

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic video image processing/light source system

• Primary Device ID: 04953170386060
• NIH Device Record Key: 79f5883c-14b7-4dd3-aa4e-323838321fee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISERA ELITE II VIDEO SYSTEM CENTER
• Version Model Number: OLYMPUS OTV-S300
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• 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

Customer Support Contacts

• Phone: +1(800)401-1086
• Email: xx@xx.xx
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170386060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193026

FDA Product Code

• FET: Endoscopic Video Imaging System/Component, Gastroenterology-Urology

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: 2021-12-27
• Device Publish Date: 2021-12-17

On-Brand Devices [VISERA ELITE II VIDEO SYSTEM CENTER]

• 04953170386060: OLYMPUS OTV-S300
• 04953170386015: OLYMPUS OTV-S200