OES CYSTONEPHROFIBERSCOPE

GUDID 04953170328817

CYF-5R Flex CystoNephro Fiberscope Rever

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible fibreoptic cystonephroscope

• Primary Device ID: 04953170328817
• NIH Device Record Key: 2b8f05b5-cfeb-4122-8ba5-e254ab0f21e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Version Model Number: OLYMPUS CYF-5R
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 1
• DM Exempt: true
• 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
• 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	04953170328817 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032092
• Premarket Notification: K221690

FDA Product Code

• FAJ: Cystoscope and accessories, flexible/rigid
• FGA: Kit, nephroscope

Sterilization

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

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

[04953170328817]

High-level Disinfectant;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-08
• Device Publish Date: 2016-09-21

On-Brand Devices [OES CYSTONEPHROFIBERSCOPE]

• 04953170339424: CYF-5A Flex CystoNephro Fiberscope w/Asp
• 04953170339417: CYF-5 Flex CystoNephro Fiberscope
• 04953170328817: CYF-5R Flex CystoNephro Fiberscope Rever
• 04953170292521: OLYMPUS CYF-5A
• 04953170292323: OLYMPUS CYF-5
• 04953170286964: OLYMPUS CYF-5A
• 04953170411182: OES CYSTONEPHROFIBERSCOPE
• 04953170411144: OES CYSTONEPHROFIBERSCOPE
• 04953170434532: OLYMPUS CYF-5