URETERO-RENO VIDEOSCOPE

GUDID 04953170343612

"URF-V2R SLIM FLEX VID URETERO SCOPE, REV"

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video ureterorenoscope, reusable

• Primary Device ID: 04953170343612
• NIH Device Record Key: 3f04b8f0-9fb7-4373-8904-9464abbe782c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: URETERO-RENO VIDEOSCOPE
• Version Model Number: OLYMPUS URF-V2R
• 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	04953170343612 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072957
• Premarket Notification: K172246

FDA Product Code

• FGB: Ureteroscope and accessories, flexible/rigid

Sterilization

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

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

[04953170343612]

Ethylene Oxide;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-12-07
• Device Publish Date: 2016-09-21

On-Brand Devices [URETERO-RENO VIDEOSCOPE]

• 04953170403392: OLYMPUS URF-V3R
• 04953170403385: OLYMPUS URF-V3
• 04953170343612: "URF-V2R SLIM FLEX VID URETERO SCOPE, REV"
• 04953170343582: OLYMPUS URF-V2
• 04953170340321: "URF-V Flex UreteroReno Videoscope"
• 04953170287183: OLYMPUS URF TYPE V
• 04953170435133: OLYMPUS URF-V3R
• 04953170435119: OLYMPUS URF-V3