R-One Robotic Platform

Organization name

ROBOCATH S.A.S

SRN

FR-MF-000003651

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this 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 with the Mobile Radioprotection Screen and the R-OneTM Consumable Kit, for Command Unit usable inside the Cathlab. 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.

Primary placement in France; available across 8 countries total.

Trade name

R-One Robotic Platform

UDI-DI code

03770024670080

Basic UDI-DI

3770024670RBH01P00004C

Reference / catalog number

RBH01P0000

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z12059099VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY -OTHER

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• Expiration date
• Manufacturing date
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