Optilume Urethral Drug Coated Balloon

Basic Information

• Brand Name: Optilume Urethral Drug Coated Balloon
• Primary DI: 00853095008334
• Version / Model: 1110
• Catalog Number: 1110-06050B
• Company Name: Urotronic, Inc.
• Labeler DUNS: 080558603
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-04
• Public Version: 1
• Public Version Date: 2022-12-12
• Public Version Status: New
• Public Device Record Key: baf8b2ad-e402-419e-8721-a8a77d846851

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QRH	Catheter, Balloon, Urethral, Drug-Coated	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
63213	Urethral dilatation catheter, drug-eluting	A sterile, flexible tube intended to be inserted into the urethra to open or increase the diameter of a constricted or irregular urethral passage; it includes a drug (e.g., chemotherapy drug) intended to be eluted in situ. The device is typically designed with an inflatable dilation balloon. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853095008334	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P210020	000

Device Sizes

Type	Value	Unit	Text
Balloon Diameter	6	Millimeter
Balloon Length	50	Millimeter
Balloon Rated Burst Pressure	12	Atmosphere

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius