EUDAMED device
TightRail Rotating Dilator Sheath
EUDAMED device 00813132021658 · Spectranetics Corporation
Key facts
| Primary DI | 00813132021658 |
|---|---|
| Trade name | TightRail Rotating Dilator Sheath |
| Device name | TightRail Rotating Dilator Sheath |
| Reference or catalog number | 545-513 |
| Manufacturer | Spectranetics Corporation |
| Manufacturer SRN | US-MF-000020669 |
| Risk class | Class III |
| EMDN code | C9002 |
| EMDN description | VASCULAR AND FASCIAL DILATORS |
| Legislation | mdd |
| Implantable | No |
| Sterile | Yes |
| Single use | Yes |
| Status date | Feb 3, 2025 |
At a glance
- Yes Matching FDA GUDID record
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About EUDAMED devices
EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.
Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date: