PerQseal® Technology e-IFUs
PerQseal®Elite is CE Mark approved. Not available for sale in the United States.
PerQseal® Technology e-IFUs
| e-IFU Name | Document Number & Revision | Product Part Number | Basic UDI-DI | Date of Publication (YYYY-MM) | Revised for Safety Reasons? | Safety Reason |
|---|---|---|---|---|---|---|
| PerQseal Elite Introducer (EU ONLY) | DP4-C56-4 Rev AG | DP4-FA1-2-G | 539153318DP4FA1INTV7 | 2025-09 | No | N/A |
| PerQseal Elite Closure Device (EU ONLY) | DP4-C56-3 Rev AJ | DP4-FA1-4-G | 539153318DP4FA1VCDV7 | 2025-09 | No | N/A |
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The Instructions for Use contain the following languages.
| Abbreviation | Language | |
|---|---|---|
| INSTRUCTIONS FOR USE | EN | English |
| GEBRAUCHSANWEISUNG | DE | German |
| MODE D’EMPLOI | FR | French |
| ISTRUZIONI PER L’USO | IT | Italian |
| GEBRUIKSAANWIJZING | NL | Dutch |
| BRUGSANVISNING | DA | Danish |
| BRUKSANSVISNING | NO | Norwegian |
| BRUKSANVISNING | SV | Swedish |
| KÄYTTÖOHJE | FI | Finnish |
| INSTRUCCIONES DE USO | ES | Spanish |
| INSTRUÇÕES DE UTILIZAÇÃO | PT | Portuguese |
| ΟΔΗΓΙΕΣ ΧΡΗΣΗΣ | EL | Greek |
| NÁVOD K POUŽITÍ | CS | Czech |
| INSTRUKCJA UŻYWANIA | PL | Polish |
| KULLANIM TALİMATLARI | TR | Turkish |
| تعلیمات الاستخدام | AR | Arabic |
e-IFU in paper form for all products are provided with each individual product packaging. If you require current version in paper form instructions for use, free of charge, please contact Vivasure Medical at ifu@vsuremed.com. The instructions for use in paper form are provided within seven (7) calendar days upon request.