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

Magellan® Autologous Platelet Separator System

Arteriocyte Medical Systems, Inc · 🇺🇸 United States
Devices (same UDI-DI)
1
Certificates
0
Countries
32
Notified Bodies
0

Basic Information

Primary DI
+M896TRU2000
Basic UDI-DI Code
++M896TRU200H8
Reference
TRU200
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 2a
Status
On The Market

Additional Description

The Magellan® Autologous Platelet Separator System is designed to be used in the clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of platelet-poor plasma and platelet concentrate (platelet rich plasma) from a small sample of blood or a small mixture of blood and bone marrow. The plasma and concentrated platelets produced can be used for diagnostic tests. Additionally, the platelet-rich plasma can be mixed with autograft and/or allograft bone prior to application to an orthopedic site. The platelet-rich plasma can be mixed prior to application to an orthopedic site as deemed necessary by the clinical use requirements.

CND Nomenclature Codes

Code Description
B0501 PLATELET GEL AUTOMATIC PREPARATION DEVICES (EXCLUDING BAGS)

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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