URETERO-RENO VIDEOSCOPE

GUDID 04953170403385

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable 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