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Terviseamet

Medical device

MSA code 13679
UDI code
Seadme klass Meditsiiniseade
Risk class III
Appliance -
Device name (in Estonian) DURAFORM™ kõvakelme siirdamise implantaat
Device name (in English) DURAFORM™ Dural Graft Implant
Intended use (is Estonian) DURAFORM kõvakelme siirdamise implantaat on mõeldud kasutamiseks spinaal- ja
kraniaalprotseduuride korral, mille käigus on vajalik kahjustunud kõvakelme parandamine
või asendamine.
Intended use (in English) The DURAFORM Dural Graft Implant is intended for use in cranial
and spinal surgical procedures where the repair or substitution
of the patient’s dura mater is needed. DURAFORM Dural Graft
Implant is also indicated as an adhesion barrier for the inhibition
of postoperative peridural fibrosis.
Type/model/article number 801475EL, 801476EL
Additional information Ainult professionaalseks kasutamiseks
Notified body 0086
Manufacturer Codman&Shurtleff, Inc.
Authorized spokesman Codman, a division of Johnson&Johnson Medical Ltd.
In register from 05/29/2019
Status Active
EHK soodustus EHK soodustus puudub
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