| Primary Device ID | 00810116023523 |
| NIH Device Record Key | d4a4703c-57ff-4a49-b1d0-7cc7a7e0a3dc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Axis II |
| Version Model Number | Dornier AXIS II E URS FLEX US - Ureteroscope |
| Catalog Number | AX20409 |
| Company DUNS | 130789944 |
| Company Name | DORNIER MEDTECH AMERICA, 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 | false |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00810116023523 [Primary] |
| FGB | Ureteroscope And Accessories, Flexible/Rigid |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-30 |
| Device Publish Date | 2026-01-22 |
| 00810116023370 - Dornier MedTech | 2026-01-30 Digital Video Processor |
| 00810116023417 - Dornier MedTech | 2026-01-30 |
| 00810116023431 - Dornier MedTech | 2026-01-30 |
| 00810116023523 - Axis II | 2026-01-30 |
| 00810116023523 - Axis II | 2026-01-30 |
| 00810116023585 - Dornier MedTech | 2026-01-30 |
| 00810116023608 - Dornier HOOVER Access Sheath | 2026-01-22 Hoover Negative Pressure Ureteral Access Sheath, 10Fr x 40 cm |
| 00810116023615 - Dornier HOOVER Access Sheath | 2026-01-22 Hoover Negative Pressure Ureteral Access Sheath, 10Fr x 50 cm |
| 00810116023622 - Dornier HOOVER Access Sheath | 2026-01-22 Hoover Negative Pressure Ureteral Access Sheath, 11Fr x 40 cm |