Optilume Urethral Drug Coated Balloon Catheter Kit
Basic Information
- Brand Name
- Optilume Urethral Drug Coated Balloon Catheter Kit
- Primary DI
- 00859937006247
- Version / Model
- 1230
- Catalog Number
- OPTBDL7000B
- Company Name
- Urotronic, Inc.
- Labeler DUNS
- 080558603
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-09
- Public Version
- 1
- Public Version Date
- 2026-02-17
- Public Version Status
- New
- Public Device Record Key
- 9649900a-6b63-4468-9d29-ffe735912bd0
Device Description
Optilume Urethral Drug Coated Balloon Catheter kit (1230-TAB) consists of an Optilume Urethral Drug Coated Balloon 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 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 | 00859937006247 | GS1 |
Customer Contacts
- Phone
- 763-285-7496
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Balloon Diameter | 6 | Millimeter | |
| Balloon Length | 30 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius