Optilume Urethral Drug Coated Balloon Catheter & Basic Catheter Kit OPTBDL7011B

GUDID 00859937006216

Optilume Urethral Drug Coated Balloon Catheter kit (1235-TAB) consists of one Optilume Urethral Drug Coated Balloon catheter, one Optilume Basic Urological Dilation catheter and an Atrion Medical Inflation device. 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. The Optilume® Basic catheter is the same catheter as the Optilume® Urethral DCB without the drug coating. The Atrion Medical QL® Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that controls the plunger, a manometer to measure pressure and a connecting tube.

Urotronic, Inc.

Urethral dilatation catheter, drug-eluting

• Primary Device ID: 00859937006216
• NIH Device Record Key: 86cfe47d-939d-45c1-b75e-ccaae812806a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optilume Urethral Drug Coated Balloon Catheter & Basic Catheter Kit
• Version Model Number: 1235
• Catalog Number: OPTBDL7011B
• 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: true
• 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

Device Dimensions

• Balloon Diameter: 10 Millimeter
• Balloon Length: 50 Millimeter
• Balloon Diameter: 10 Millimeter
• Balloon Length: 50 Millimeter
• Balloon Diameter: 10 Millimeter
• Balloon Length: 50 Millimeter
• Balloon Diameter: 10 Millimeter
• Balloon Length: 50 Millimeter
• Balloon Diameter: 10 Millimeter
• Balloon Length: 50 Millimeter
• Balloon Diameter: 10 Millimeter
• Balloon Length: 50 Millimeter
• Balloon Diameter: 10 Millimeter
• Balloon Length: 50 Millimeter
• Balloon Diameter: 10 Millimeter
• Balloon Length: 50 Millimeter
• Balloon Diameter: 10 Millimeter
• Balloon Length: 50 Millimeter
• Balloon Diameter: 10 Millimeter
• Balloon Length: 50 Millimeter
• Balloon Diameter: 10 Millimeter
• Balloon Length: 50 Millimeter
• Balloon Diameter: 10 Millimeter
• Balloon Length: 50 Millimeter

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859937006216 [Primary]

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: 2026-02-17
• Device Publish Date: 2026-02-09

On-Brand Devices [Optilume Urethral Drug Coated Balloon Catheter & Basic Catheter Kit]

• 00859937006216: Optilume Urethral Drug Coated Balloon Catheter kit (1235-TAB) consists of one Optilume Urethral
• 00859937006209: Optilume Urethral Drug Coated Balloon Catheter kit (1235-TAB) consists of one Optilume Urethral
• 00859937006193: Optilume Urethral Drug Coated Balloon Catheter kit (1235-TAB) consists of one Optilume Urethral
• 00859937006186: Optilume Urethral Drug Coated Balloon Catheter kit (1235-TAB) consists of one Optilume Urethral