VISERA ELITE II XENON LIGHT SOURCE

GUDID 04953170428142

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic light source, line-powered

• Primary Device ID: 04953170428142
• NIH Device Record Key: 97de7989-a288-4660-b814-d8b5af8469dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISERA ELITE II XENON LIGHT SOURCE
• Version Model Number: OLYMPUS CLV-S200-IR
• 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: true
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)401-1086
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Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170428142 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200542

FDA Product Code

• NWB: Endoscope, accessories, narrow band spectrum

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: 2021-03-11
• Device Publish Date: 2021-03-03

On-Brand Devices [VISERA ELITE II XENON LIGHT SOURCE]

• 04953170386138: OLYMPUS CLV-S200-IR
• 04953170428142: OLYMPUS CLV-S200-IR