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Issuing CEFTA Economy
Serbia
BTI Reference
1989/17
Validity Start Date
15/06/2017
Validity End Date
15/06/2020
Nomenclature code
9021909000
Justification
Language
Српски језик
Issuing place
Beograd
Issuing date
Goods description
Predmetna roba je gel implant za glaukom koji je umetnut u injektor. Namenjen je za kreiranje kanala kroz beonjacu koji omogucuje protok vodene tecnosti iz prednje komore u subkonjuktivalni prostor da bi se smanjio intraokularni pritisak (IOP). Gel implant se uvodi pomocu injektora kroz mali rez na rožnjaci. Gel imlant se sastoji od želatina napravl?enog od svinjske kože koji se širi i postaje fleksibilan kada se hidrira. Širenje spol?nog precnika cevcice doprinosi zadržavanju gel imlanta na predvidenom mestu nakon hiruške imlantacije. Gel imlant se ubacuje u injektor koji drži gel imlant za vreme umetanja i isporuke u oko. Injektor hirurgu omogucuje da vodi i isporuci gel imlant do žel?enog mesta. Gel imlant ima dužinu 6 mm, spol?ni precnik 150um i unutrašnji precnik 45 um. Injektor sa umetnutim gel implatnom se isporucuje u sterilnom i apirogenom stanju na tacni zatvorenoj poklopcem. Zatvorena tacna se stavl?a u kutiju za jedinicu sa oznakama i informacijama o proizvodu. Gel imlant i injektor su sterilisani zracenjem.
National keywords
Gel implant
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