Plateforme robotique R-One

Nom de l'organisation

ROBOCATH S.A.S

SRN

FR-MF-000003651

Statut du fabricant

Actif

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• CW010

  EUDAMED n'a pas publié de description pour ce code.
• CW011

  The system should only be used by interventional cardiologists and their staff, who have received specific training for the use of the R-OneTM device. The training provided by Robocath is limited to the use of the system and does not replace the expertise and medical training necessary to perform coronary angioplasty. The movement of the guidewire and/or stent/balloon catheter with the system should not be performed without viewing them using X-rays. The navigation speed of the guidewire and/or stent/balloon catheter should be adapted to the arterial areas traversed. The fast navigation mode should only be used when the guidewire and the stent/balloon catheter are in the guide catheter. The R-OneTM system is not recommended for heavily calcified lesions, ostial lesions, and chronic total occlusions (CTOs). The R-OneTM Robotic Platform is designed to be used exclusively in combination with the R-OneTM Consumable Kit, for command unit usable inside the control room. Mobile Radioprotection Screen can be used as an option. The R-OneTM system is only compatible with: • 0.014" guidewires • Rapid exchange stent/balloon catheters • Y connectors (Super KetchTM by Minvasys, Honor® Hemostasis Valve by Merit Medical) For an optimal use of the system, it is recommended to use a 6 Fr guiding catheter minimum.

Marché principal en France ; disponible dans 8 pays au total.

Dénomination commerciale

Plateforme robotique R-One

Code d'UDI-DI

03770024670028

Basic UDI-DI

3770024670RBH01P00004C

Numéro de référence/catalogue

RBH01P0001

Entité d'attribution

GS1

Catégorie de risque

Classe IIb

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

—

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z12059099VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY -OTHER

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