EUDAMED device
Comfort Cool Gladiator Wrist & Thumb Orthosis, Small, Left
EUDAMED device 00768627013772 · North Coast Medical Inc.
Key facts
| Primary DI | 00768627013772 |
|---|---|
| Trade name | Comfort Cool Gladiator Wrist & Thumb Orthosis, Small, Left |
| Device name | Gladiator Wrist Thumb Orthosis |
| Reference or catalog number | NC86650 |
| Model | 4113 |
| Manufacturer | North Coast Medical Inc. |
| Manufacturer SRN | US-MF-000009087 |
| Risk class | Class I |
| EMDN code | Y060613 |
| EMDN description | WRIST-HAND-FINGERS ORTHOSES |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Dec 19, 2025 |
At a glance
- No 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: