URETERO-RENO FIBERSCOPE N5781944

GUDID 04953170435102

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible fibreoptic ureterorenoscope

• Primary Device ID: 04953170435102
• NIH Device Record Key: 56bfcd42-cce8-4ac1-b8e7-062d046a8885
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: URETERO-RENO FIBERSCOPE
• Version Model Number: OLYMPUS URF-P7R
• Catalog Number: N5781944
• 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: false
• 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
• Phone: +1(800)401-1086
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170435102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181451

FDA Product Code

• FGB: Ureteroscope And Accessories, Flexible/Rigid

Sterilization

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

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

[04953170435102]

Hydrogen Peroxide;Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-28
• Device Publish Date: 2023-04-20

On-Brand Devices [URETERO-RENO FIBERSCOPE]

• 04953170403835: OLYMPUS URF-P7R
• 04953170403811: OLYMPUS URF-P7
• 04953170340833: "URF-P6R SUPER-SLIM FLEXIBLE FIBEROPTIC U"
• 04953170340802: "URF-P6 SUPER-SLIM FLEXIBLE FIBEROPTIC UR"
• 04953170435102: OLYMPUS URF-P7R
• 04953170435096: OLYMPUS URF-P7