AVANTI™+ Transradial Introducer Kit

Primary DI

10705032010320

Basic UDI-DI Code

07050320000000000000011C6

Reference

504-626Z

Device Types

Cmr substance Endocrine disruptor Single use Sterile

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Cordis US Corporation

A catheter sheath introducer (CSI) has a hydrophobic coating and facilitates percutaneous entry of an intravascular device. Color coding indicates the French size of the largest intravascular device that will pass through the CSI. The availability of French sizes varies per product line. Refer to product catalog for availability. French Color 4 Red, 5 Gray, 6 Green, 7 Orange. Vessel Dilator (Included): A vessel dilator facilitates the percutaneous entry of the CSI by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel. The vessel dilator has a hydrophobic coating to facilitate insertion and withdrawal during vessel access. Needle (Included): A needle is provided to facilitate entry into the artery. Refer to product labeling for the size. Mini-Guidewire (Included): A mini-guidewire is provided for maintaining access to the puncture site upon removal of the needle and before the insertion of the CSI. Refer to product labeling for the size.

The Basic UDI-DI associated with this device has 7 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).