EUDAMED device
GPSA-2
EUDAMED device 00198168267684 · Impulse Technology LLC
Key facts
| Primary DI | 00198168267684 |
|---|---|
| Trade name | GPSA-2 |
| Device name | Goralign PSA 2 |
| Reference or catalog number | GPSA-2QY |
| Model | GPSA-2QY |
| Manufacturer | Impulse Technology LLC |
| Manufacturer SRN | US-MF-000042177 |
| Risk class | Class I |
| EMDN code | P0905060201,P0905060202 |
| EMDN description | ANKLE PROSTHESES WITH UNCEMENTED MOBILE INSERT - TALAR COMPONENTS|ANKLE PROSTHESES WITH UNCEMENTED MOBILE INSERT - TIBIAL COMPONENTS |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | Yes |
| Status date | May 28, 2024 |
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: