Eu Mdr Eu Md Class 1 On The Market

EPIONE RoboKit

The EPIONE RoboKit is used during the CT guided procedures performed with EPIONE. Sterile drapes are used to cover: • the robotic arm, • the touchscreen of the display cart, • the tray of the display cart supporting the mouse and the keyboard. Reflective spheres to be placed on the tracked EPIONE instruments. The EPIONE RoboKit includes the accessories individually packaged in their primary packaging considered as sterile, but the EPIONE RoboKit is not sterile.

Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
03760305400260
Basic UDI-DI Code
37603054003RKYD
Reference
09-0057
Device Types
Sterile
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
On The Market

Additional Description

The EPIONE RoboKit is used during the CT guided procedures performed with EPIONE. Sterile drapes are used to cover: • the robotic arm, • the touchscreen of the display cart, • the tray of the display cart supporting the mouse and the keyboard. Reflective spheres to be placed on the tracked EPIONE instruments.

Medical Purpose

The EPIONE RoboKit is used during the CT guided procedures performed with EPIONE. Sterile drapes are used to cover: • the robotic arm, • the touchscreen of the display cart, • the tray of the display cart supporting the mouse and the keyboard. Reflective spheres to be placed on the tracked EPIONE instruments. The EPIONE RoboKit includes the accessories individually packaged in their primary packaging considered as sterile, but the EPIONE RoboKit is not sterile.

CND Nomenclature Codes

Code Description
V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER

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