VISERA CYSTO-NEPHRO VIDEOSCOPE

GUDID 04953170339455

CYF-VA2 Flex CystoNephro Videoscope wAsp

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video cystonephroscope

• Primary Device ID: 04953170339455
• NIH Device Record Key: 544e57c1-6d91-43fe-a8b3-96fb287f4d2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Version Model Number: OLYMPUS CYF- TYPE VA2
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170339455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062049

FDA Product Code

• NWB: Endoscope, accessories, narrow band spectrum

Sterilization

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

[04953170339455]

High-level Disinfectant;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [VISERA CYSTO-NEPHRO VIDEOSCOPE]

• 04953170339523: CYF-V2R Flex CystoNephro Videoscope Rev
• 04953170339455: CYF-VA2 Flex CystoNephro Videoscope wAsp
• 04953170339431: CYF-V2 Flex CystoNephro Videoscope
• 04953170287619: OLYMPUS CYF TYPE V2R
• 04953170287145: OLYMPUS CYF- TYPE VA2
• 04953170287091: OLYMPUS CYF TYPE V2
• 04953170411212: VISERA CYSTO-NEPHRO VIDEOSCOPE
• 04953170411199: VISERA CYSTO-NEPHRO VIDEOSCOPE