Eu Mdr Eu Md Class 2a On The Market 🇺🇸 United States

RAIN Sheath™ Transradial Introducer

Cordis US Corporation · 🇺🇸 United States
Devices (same UDI-DI)
16
Certificates
0
Countries
32
Notified Bodies
0

Basic Information

Primary DI
10705032082082
Basic UDI-DI Code
07050320000000000000068D3
Reference
506616P22G
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

Additional Description

Catheter Sheath Introducer (CSI, Included): A catheter sheath introducer (CSI) facilitates percutaneous entry of an intravascular device. Vessel Dilator (Included): A vessel dilator with a lubricious coating facilitates the percutaneous entry of the CSI by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel. Mini-Guidewire (Included): A 0.021” diameter, mini-guidewire is provided for establishing vessel access. IV Catheter Needle (Included for some configurations): An IV Catheter access needle is provided with the hydrophilic wire and polymer wire kit options to facilitate initial entry into the artery. Bare Needle (Included for some configurations): A bare access needle with a lubricious, hydrophobic coating is provided for the bare wire and nitinol wire kit options. It also facilitates initial entry into the artery.

CND Nomenclature Codes

Code Description
C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED

Available In Countries

🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇾 Cyprus 🇨🇿 Czechia 🇩🇪 Germany 🇩🇰 Denmark 🇪🇪 Estonia 🇬🇷 Greece 🇪🇸 Spain 🇫🇮 Finland 🇫🇷 France 🇭🇷 Croatia 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇸 Iceland 🇮🇹 Italy 🇱🇮 Liechtenstein 🇱🇹 Lithuania 🇱🇺 Luxembourg 🇱🇻 Latvia 🇲🇹 Malta 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇪 Sweden 🇸🇮 Slovenia 🇸🇰 Slovakia 🇹🇷 Türkiye 🇬🇧 United Kingdom

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The Basic UDI-DI associated with this device has 16 devices in total. Below are some other devices sharing the same Basic UDI-DI.

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