| Primary Device ID | 00810116023615 |
| NIH Device Record Key | c0a9875a-8758-48f7-be56-5137a7a4a61c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dornier HOOVER Access Sheath |
| Version Model Number | IVX-NS-1050 |
| Catalog Number | IVX-NS-1050 |
| 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 | 00810116023615 [Primary] |
| GS1 | 10810116023612 [Package] Package: [20 Units] In Commercial Distribution |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-22 |
| Device Publish Date | 2026-01-14 |
| 00810116023752 | Hoover Urological Sampler Sets |
| 00810116023653 | Hoover Negative Pressure Ureteral Access Sheath, 12Fr x 50 cm |
| 00810116023646 | Hoover Negative Pressure Ureteral Access Sheath, 12Fr x 40 cm |
| 00810116023639 | Hoover Negative Pressure Ureteral Access Sheath, 11Fr x 50 cm |
| 00810116023622 | Hoover Negative Pressure Ureteral Access Sheath, 11Fr x 40 cm |
| 00810116023615 | Hoover Negative Pressure Ureteral Access Sheath, 10Fr x 50 cm |
| 00810116023608 | Hoover Negative Pressure Ureteral Access Sheath, 10Fr x 40 cm |