| Primary Device ID | 00853095008334 |
| NIH Device Record Key | baf8b2ad-e402-419e-8721-a8a77d846851 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Optilume Urethral Drug Coated Balloon |
| Version Model Number | 1110 |
| Catalog Number | 1110-06050B |
| 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 | 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 |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 50 Millimeter |
| Balloon Rated Burst Pressure | 12 Atmosphere |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 50 Millimeter |
| Balloon Rated Burst Pressure | 12 Atmosphere |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 50 Millimeter |
| Balloon Rated Burst Pressure | 12 Atmosphere |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 50 Millimeter |
| Balloon Rated Burst Pressure | 12 Atmosphere |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 50 Millimeter |
| Balloon Rated Burst Pressure | 12 Atmosphere |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 50 Millimeter |
| Balloon Rated Burst Pressure | 12 Atmosphere |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 50 Millimeter |
| Balloon Rated Burst Pressure | 12 Atmosphere |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 50 Millimeter |
| Balloon Rated Burst Pressure | 12 Atmosphere |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 50 Millimeter |
| Balloon Rated Burst Pressure | 12 Atmosphere |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 50 Millimeter |
| Balloon Rated Burst Pressure | 12 Atmosphere |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 50 Millimeter |
| Balloon Rated Burst Pressure | 12 Atmosphere |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 50 Millimeter |
| Balloon Rated Burst Pressure | 12 Atmosphere |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 50 Millimeter |
| Balloon Rated Burst Pressure | 12 Atmosphere |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 50 Millimeter |
| Balloon Rated Burst Pressure | 12 Atmosphere |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 50 Millimeter |
| Balloon Rated Burst Pressure | 12 Atmosphere |
| 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 |
| 00853095008334 | The Optilume® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over |
| 00853095008327 | The Optilume® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over |
| 00853095008310 | The Optilume® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over |
| 00853095008303 | The Optilume® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over |
| 00853095008297 | The Optilume® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over |
| 00853095008280 | The Optilume® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over |
| 00853095008273 | The Optilume® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over |
| 00853095008242 | The Optilume® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over |