Uro-N Cystoscope 1115

GUDID 00860008483720

The Uro-N cystoscope system consists of a mulit-use handle with an LCD screeen and a single-use sterile cannula. The Uro-N is intended fr directed injection of therapeutic agents and solutions into target areas of the bladder and the lower urinary tract via a cystoscope.

UROVIU CORP.

Rigid optical cystoscope

• Primary Device ID: 00860008483720
• NIH Device Record Key: d85aa789-55ae-49b2-9f98-0e4dfd734ded
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uro-N Cystoscope
• Version Model Number: 1115
• Catalog Number: 1115
• Company DUNS: 118239699
• Company Name: UROVIU 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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: 650 397 5174
• Email: cs@uroviu.com
• Phone: 650 397 5174
• Email: cs@uroviu.com
• Phone: 650 397 5174
• Email: cs@uroviu.com
• Phone: 650 397 5174
• Email: cs@uroviu.com
• Phone: 650 397 5174
• Email: cs@uroviu.com
• Phone: 650 397 5174
• Email: cs@uroviu.com
• Phone: 650 397 5174
• Email: cs@uroviu.com
• Phone: 650 397 5174
• Email: cs@uroviu.com
• Phone: 650 397 5174
• Email: cs@uroviu.com
• Phone: 650 397 5174
• Email: cs@uroviu.com
• Phone: 650 397 5174
• Email: cs@uroviu.com
• Phone: 650 397 5174
• Email: cs@uroviu.com
• Phone: 650 397 5174
• Email: cs@uroviu.com
• Phone: 650 397 5174
• Email: cs@uroviu.com
• Phone: 650 397 5174
• Email: cs@uroviu.com
• Phone: 650 397 5174
• Email: cs@uroviu.com
• Phone: 650 397 5174
• Email: cs@uroviu.com

Device Dimensions

• Length: 269 Millimeter
• Length: 269 Millimeter
• Length: 269 Millimeter
• Length: 269 Millimeter
• Length: 269 Millimeter
• Length: 269 Millimeter
• Length: 269 Millimeter
• Length: 269 Millimeter
• Length: 269 Millimeter
• Length: 269 Millimeter
• Length: 269 Millimeter
• Length: 269 Millimeter
• Length: 269 Millimeter
• Length: 269 Millimeter
• Length: 269 Millimeter
• Length: 269 Millimeter
• Length: 269 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008483720 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182876

FDA Product Code

• FAJ: Cystoscope And Accessories, Flexible/Rigid

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-11-17
• Device Publish Date: 2022-12-16

Devices Manufactured by UROVIU CORP.

• 00860008483713 - Uro-V Cystoscope: 2023-11-17 The Uro-V cystoscope system consists of a multi-use handle with an LCD screen and a single-use cannula. The system is used for e
• 00860008483720 - Uro-N Cystoscope: 2023-11-17The Uro-N cystoscope system consists of a mulit-use handle with an LCD screeen and a single-use sterile cannula. The Uro-N is intended fr directed injection of therapeutic agents and solutions into target areas of the bladder and the lower urinary tract via a cystoscope.
• 00860008483720 - Uro-N Cystoscope: 2023-11-17 The Uro-N cystoscope system consists of a mulit-use handle with an LCD screeen and a single-use sterile cannula. The Uro-N is in