EUDAMED device
Ultra Stiff Fixed Core Wire Guide
EUDAMED device 00827002535664 · Cook Incorporated
Key facts
| Primary DI | 00827002535664 |
|---|---|
| Trade name | Ultra Stiff Fixed Core Wire Guide |
| Device name | Urology Wire Guides [Amplatz Fixed Core: Extra Stiff, Stiff, Ultra Stiff (Double Flexible)]; [PTFE: (Bentson With 15cm Flexible Tip) (Heavy Duty) (With 3cm Flexible Tip) (With Safe-T-J® Tip)] |
| Reference or catalog number | AUS-035145 |
| Manufacturer | Cook Incorporated |
| Manufacturer SRN | US-MF-000003180 |
| Risk class | Class IIa |
| EMDN code | U0602 |
| EMDN description | UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC |
| Legislation | mdr |
| Implantable | No |
| Sterile | Yes |
| Single use | Yes |
| Status date | Nov 18, 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: