URETERO-RENO VIDEOSCOPE

GUDID 04953170403385

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video ureterorenoscope, reusable

• Primary Device ID: 04953170403385
• NIH Device Record Key: fb73ef88-1154-430a-bba6-2a5cb7a359e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: URETERO-RENO VIDEOSCOPE
• Version Model Number: OLYMPUS URF-V3
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170403385 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181451

FDA Product Code

• NWB: Endoscope, accessories, narrow band spectrum

Sterilization

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

[04953170403385]

Hydrogen Peroxide;Ethylene Oxide

[04953170403385]

Hydrogen Peroxide;Ethylene Oxide

[04953170403385]

Hydrogen Peroxide;Ethylene Oxide

[04953170403385]

Hydrogen Peroxide;Ethylene Oxide

[04953170403385]

Hydrogen Peroxide;Ethylene Oxide

[04953170403385]

Hydrogen Peroxide;Ethylene Oxide

[04953170403385]

Hydrogen Peroxide;Ethylene Oxide

[04953170403385]

Hydrogen Peroxide;Ethylene Oxide

[04953170403385]

Hydrogen Peroxide;Ethylene Oxide

[04953170403385]

Hydrogen Peroxide;Ethylene Oxide

[04953170403385]

Hydrogen Peroxide;Ethylene Oxide

[04953170403385]

Hydrogen Peroxide;Ethylene Oxide

[04953170403385]

Hydrogen Peroxide;Ethylene Oxide

[04953170403385]

Hydrogen Peroxide;Ethylene Oxide

[04953170403385]

Hydrogen Peroxide;Ethylene Oxide

[04953170403385]

Hydrogen Peroxide;Ethylene Oxide

[04953170403385]

Hydrogen Peroxide;Ethylene Oxide

[04953170403385]

Hydrogen Peroxide;Ethylene Oxide

[04953170403385]

Hydrogen Peroxide;Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-11

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