VISERA ELITE XENON LIGHT SOURCE

GUDID 04953170301995

CLV-S190 VISERA ELITE XENON LIGHT SRCE

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic light source, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered

• Primary Device ID: 04953170301995
• NIH Device Record Key: 34c3a9c8-2ffb-4326-bebc-ddc5fb714e9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISERA ELITE XENON LIGHT SOURCE
• Version Model Number: OLYMPUS CLV-S190
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170301995 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111425

FDA Product Code

• EOQ: BRONCHOSCOPE (FLEXIBLE OR RIGID)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-09-21

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• 14953170460330 - Single Use Biliary Drainage Stent V: 2024-04-02
• 14953170460378 - Single Use Biliary Drainage Stent V: 2024-04-02
• 14953170460613 - Single Use Biliary Drainage Stent V: 2024-04-02