Optilume Basic Urological Dilation catheter 1147-10030

GUDID 00853095008389

The Optilume Basic Urological Balloon Dilation Catheter (Optilume Basic) is a 0.038” (0.97 mm) guidewire and flexible cystoscope compatible over-the-wire (OTW) catheter with a dual lumen design with a tapered atraumatic tip. The Optilume Basic is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter is a semi-compliant inflatable balloon. The usable length is 75 cm and allows the device to be compatible with the working channel of a standard flexible cystoscope. The device has two radiopaque marker bands that indicate the working length of the balloon.

Urotronic, Inc.

Urethral dilator, single-use

• Primary Device ID: 00853095008389
• NIH Device Record Key: 52228ac3-99c4-4dc0-ac31-866f3d2b180c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optilume Basic Urological Dilation catheter
• Version Model Number: 1147
• Catalog Number: 1147-10030
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853095008389 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191061

FDA Product Code

• KOE: Dilator, Urethral

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: 2025-07-28
• Device Publish Date: 2025-07-18

On-Brand Devices [Optilume Basic Urological Dilation catheter]

• 00853095008396: The Optilume Basic Urological Balloon Dilation Catheter (Optilume Basic) is a 0.038” (0.97 mm)
• 00853095008389: The Optilume Basic Urological Balloon Dilation Catheter (Optilume Basic) is a 0.038” (0.97 mm)
• 00853095008372: The Optilume Basic Urological Balloon Dilation Catheter (Optilume Basic) is a 0.038” (0.97 mm)
• 00853095008365: The Optilume Basic Urological Balloon Dilation Catheter (Optilume Basic) is a 0.038” (0.97 mm)
• 00853095008358: The Optilume Basic Urological Balloon Dilation Catheter (Optilume Basic) is a 0.038” (0.97 mm)
• 00853095008341: The Optilume Basic Urological Balloon Dilation Catheter (Optilume Basic) is a 0.038” (0.97 mm)