Optilume BPH Pre-dilation Catheter 1137-30030

GUDID 00853095008426

The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body.

Urotronic, Inc.

Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated

• Primary Device ID: 00853095008426
• NIH Device Record Key: aad34aab-3c47-48ac-891b-ecefdbdca5e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optilume BPH Pre-dilation Catheter
• Version Model Number: 1137
• Catalog Number: 1137-30030
• 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: false
• 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
• Phone: 763.285.7496
• Email: optilume@urotronic.com
• Phone: 763.285.7496
• Email: optilume@urotronic.com

Device Dimensions

• Balloon Diameter: 30 Millimeter
• Catheter Length: 30 Millimeter
• Balloon Rated Burst Pressure: 4 Atmosphere
• Balloon Diameter: 30 Millimeter
• Catheter Length: 30 Millimeter
• Balloon Rated Burst Pressure: 4 Atmosphere
• Balloon Diameter: 30 Millimeter
• Catheter Length: 30 Millimeter
• Balloon Rated Burst Pressure: 4 Atmosphere
• Balloon Diameter: 30 Millimeter
• Catheter Length: 30 Millimeter
• Balloon Rated Burst Pressure: 4 Atmosphere
• Balloon Diameter: 30 Millimeter
• Catheter Length: 30 Millimeter
• Balloon Rated Burst Pressure: 4 Atmosphere
• Balloon Diameter: 30 Millimeter
• Catheter Length: 30 Millimeter
• Balloon Rated Burst Pressure: 4 Atmosphere
• Balloon Diameter: 30 Millimeter
• Catheter Length: 30 Millimeter
• Balloon Rated Burst Pressure: 4 Atmosphere
• Balloon Diameter: 30 Millimeter
• Catheter Length: 30 Millimeter
• Balloon Rated Burst Pressure: 4 Atmosphere
• Balloon Diameter: 30 Millimeter
• Catheter Length: 30 Millimeter
• Balloon Rated Burst Pressure: 4 Atmosphere
• Balloon Diameter: 30 Millimeter
• Catheter Length: 30 Millimeter
• Balloon Rated Burst Pressure: 4 Atmosphere
• Balloon Diameter: 30 Millimeter
• Catheter Length: 30 Millimeter
• Balloon Rated Burst Pressure: 4 Atmosphere
• Balloon Diameter: 30 Millimeter
• Catheter Length: 30 Millimeter
• Balloon Rated Burst Pressure: 4 Atmosphere
• Balloon Diameter: 30 Millimeter
• Catheter Length: 30 Millimeter
• Balloon Rated Burst Pressure: 4 Atmosphere
• Balloon Diameter: 30 Millimeter
• Catheter Length: 30 Millimeter
• Balloon Rated Burst Pressure: 4 Atmosphere
• Balloon Diameter: 30 Millimeter
• Catheter Length: 30 Millimeter
• Balloon Rated Burst Pressure: 4 Atmosphere
• Balloon Diameter: 30 Millimeter
• Catheter Length: 30 Millimeter
• Balloon Rated Burst Pressure: 4 Atmosphere
• Balloon Diameter: 30 Millimeter
• Catheter Length: 30 Millimeter
• Balloon Rated Burst Pressure: 4 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
• 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	00853095008426 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P220029

FDA Product Code

• QXB: Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia

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: 2023-08-14
• Device Publish Date: 2023-08-05

On-Brand Devices [Optilume BPH Pre-dilation Catheter]

• 00853095008426: The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therap
• 00853095008150: The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therap