CYSTO-NEPHRO VIDEOSCOPE

GUDID 04953170310508

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video cystonephroscope

• Primary Device ID: 04953170310508
• NIH Device Record Key: 388227d9-691a-4667-8185-cbb2a2a39b9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Version Model Number: OLYMPUS CYF-VHA
• 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
• Phone: +1(800)401-1086
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170310508 [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

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

[04953170310508]

Ethylene Oxide;High-level Disinfectant

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 [CYSTO-NEPHRO VIDEOSCOPE]

• 04953170310522: CYF-VHR HD FlexCystoNephroVideoscope Rev
• 04953170310508: OLYMPUS CYF-VHA
• 04953170310461: CYF-VH HD Flex CystoNephro Videoscope
• 04953170411298: CYSTO-NEPHRO VIDEOSCOPE
• 04953170411274: CYSTO-NEPHRO VIDEOSCOPE
• 04953170411250: CYSTO-NEPHRO VIDEOSCOPE
• 04953170434730: OLYMPUS CYF-VHR