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Terviseamet

Medical device

MSA code 13684
UDI code
Seadme klass Meditsiiniseade
Risk class III
Appliance -
Device name (in Estonian) VACU-MIX PLUS EELTÄIDETUD DEPUY CMW 3 GENTAMÜTSIINIGA LUUTSEMENDIGA
Device name (in English) VACU-MIX PLUS PRE-PACKED WITH DEPUY CMW 3 GENTAMICIN BONE CEMENT
Intended use (is Estonian) Antibiootikumiga luutsemedid DePuy CMW 3 gentamütsiiniga on näidustatud proteeside fikseerimiseks elusluu külge liigeste artroplastilistel protseduuridel, mille puhul nakatumine gentamütsiini suhtes tundlike organismidega on potentsiaalne oht.
Intended use (in English) The antibiotic bone cement DePuy CMW 3 Gentamicin bone cements are indicated for the fixation of prostheses to living bone in arthroplasty procedures of joints in which infection by gentamicin sensitive organisms is a potential risk.
Type/model/article number 3005050, 3005080
Notified body 2797
Manufacturer DePuy Ireland UC
In register from 05/30/2019
Status Active
EHK soodustus EHK soodustus puudub
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