Optilume Urethral Drug Coated Balloon 1110-12030B

GUDID 00853095008242

The Optilume® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over-the-wire (OTW) guidewire compatible catheter with a dual lumen design and a tapered, atraumatic tip. The Optilume DCB is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter has a semi-compliant inflatable balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel. The drug coating covers the working length of the balloon body. The device has two radiopaque marker bands that indicate the working length of the balloon where the drug coating is applied. The drug coated balloon is covered with a protective sheath that is discarded prior to use.

Urotronic, Inc.

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• Primary Device ID: 00853095008242
• NIH Device Record Key: 7ddef985-2c1f-4f67-908a-ebb8af77fbbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optilume Urethral Drug Coated Balloon
• Version Model Number: 1110
• Catalog Number: 1110-12030B
• Company DUNS: 080558603
• Company Name: Urotronic, Inc.
• 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: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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: 763.285.7496
• Email: optilume@urotronic.com
• Phone: 763.285.7496
• Email: optilume@urotronic.com
• Phone: 763.285.7496
• Email: optilume@urotronic.com
• Phone: 763.285.7496
• Email: optilume@urotronic.com
• Phone: 763.285.7496
• Email: optilume@urotronic.com
• Phone: 763.285.7496
• Email: optilume@urotronic.com
• Phone: 763.285.7496
• Email: optilume@urotronic.com
• Phone: 763.285.7496
• Email: optilume@urotronic.com
• Phone: 763.285.7496
• Email: optilume@urotronic.com
• Phone: 763.285.7496
• Email: optilume@urotronic.com
• Phone: 763.285.7496
• Email: optilume@urotronic.com
• Phone: 763.285.7496
• Email: optilume@urotronic.com
• Phone: 763.285.7496
• Email: optilume@urotronic.com
• Phone: 763.285.7496
• Email: optilume@urotronic.com
• Phone: 763.285.7496
• Email: optilume@urotronic.com

Device Dimensions

• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Balloon Rated Burst Pressure: 8 Atmosphere
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Balloon Rated Burst Pressure: 8 Atmosphere
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Balloon Rated Burst Pressure: 8 Atmosphere
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Balloon Rated Burst Pressure: 8 Atmosphere
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Balloon Rated Burst Pressure: 8 Atmosphere
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Balloon Rated Burst Pressure: 8 Atmosphere
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Balloon Rated Burst Pressure: 8 Atmosphere
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Balloon Rated Burst Pressure: 8 Atmosphere
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Balloon Rated Burst Pressure: 8 Atmosphere
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Balloon Rated Burst Pressure: 8 Atmosphere
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Balloon Rated Burst Pressure: 8 Atmosphere
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Balloon Rated Burst Pressure: 8 Atmosphere
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Balloon Rated Burst Pressure: 8 Atmosphere
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Balloon Rated Burst Pressure: 8 Atmosphere
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Balloon Rated Burst Pressure: 8 Atmosphere

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853095008242 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P210020

FDA Product Code

• QRH: Catheter, Balloon, Urethral, Drug-Coated

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-12
• Device Publish Date: 2022-12-04

On-Brand Devices [Optilume Urethral Drug Coated Balloon ]

• 00853095008334: The Optilume® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over
• 00853095008327: The Optilume® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over
• 00853095008310: The Optilume® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over
• 00853095008303: The Optilume® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over
• 00853095008297: The Optilume® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over
• 00853095008280: The Optilume® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over
• 00853095008273: The Optilume® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over
• 00853095008242: The Optilume® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over