Eu Mdd Eu Md Class 2b On The Market 🇹🇷 Türkiye

ZİMED MEDİKAL SANAYİ VE TİCARET LİMİTED ŞİRKETİ

Devices (same UDI-DI)
1
Certificates
1
Countries
32
Notified Bodies
1

Basic Information

Primary DI
D-8699131618448E8
Basic UDI-DI Code
B-8699131618448E8
Reference
6041-2030
Device Types
Single use Sterilization
Regulation
Eu Mdd
Classification
Eu Md Class 2b
Status
On The Market

Additional Description

has 4 different types including trocar tip, bayonet tip, diamond Kirschner wire and threaded Kirschner wire used in the fixation of bone fractures. The trocar-tipped Kirschner wire has 2 different length options as 150 mm and 300 mm at Ø 0,8 size, 4 different length options as 250, 275, 300, and 400 mm at Ø 1,0 mm, and 3 different length options as 250, 300, and 400 mm at Ø 1,2 mm. At Ø 1,4 mm, there is 150 mm length option, and at Ø 1,5 mm, there are 5 different length options as 150, 250, 275, 300, and 400 mm. At Ø 1,8 mm, there are 3 different length options as 275, 300, and 400 mm. At Ø 2,6 mm, there is one single length of 300 mm. At Ø 3,0 mm, there are 3 different length options as 275, 300, and 400 mm. Bayonet-tip Kirschner wire has 4 different length options as 300 mm and 400 mm at Ø 1,8 ad Ø 2,0 mm. The threaded Kirschner wire comes with length options of Ø 0.5 X 250 mm, Ø 0.5 X 300 mm, Ø 0.8 X 250 mm, Ø 0.8 X 300 mm, 2 options of Ø 0.8 X 350 mm and 400 mm, 4 different options at Ø 1.0 as 250 mm, 300 mm, 350 mm, and 400 mm, one length option of Ø 1.2 X 300 mm, two length options of Ø 1.5 X 150 mm and 300 mm, and 4 length options of Ø 1.8 X 250 mm, 300 mm, 350 mm, and 400 mm. There are 6 options of Ø 2.0 X 200 mm, 250 mm, 280 mm, 300 mm, 350 mm, and 400 mm. There is one length option of Ø 2.2 X 300 mm. There are 4 length options of Ø 2.5 X 250 mm, 300 mm, 350 mm and 400 mm. There are 3 length options of Ø 3.0 X 250 mm, Ø 3.0 X 300 mm, 350 mm, and 400 mm. There are 4 length options of Ø 3.5 X 250 mm, 300 mm, 350 mm, and 400 mm.Diamond-tip Kirschner wire has one length of Ø2x440 mm.Kirschner wires are made from implant steel complying with the ISO 5832-1 standard and put into the market in non-sterile form.

CND Nomenclature Codes

Code Description
P09120301 KIRSCHNER BONE WIRES

Certificates

Type Number
MDD Annex II (excluding section 4) 1984-MDD-11-129

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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