BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    XTRA Autotransfusion Cell Separator

    Reg #: 3011554160 · FEI: 3011554160 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    20
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Steril Verona srl
    Registration Number
    3011554160
    FEI Number
    3011554160
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Fontana 3
    City
    Nogara Verona
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K101586

    Owner / Operator

    Firm Name
    STERIL VERONA s.r.l.
    Operator Number
    10023713
    Address
    Via San Giuseppe, 31
    City
    ERBE'
    State
    Verona
    Postal Code
    37060
    Country
    IT
    Correspondent
    Ottavio De Santi

    US Agent

    Business Name
    MEDAGENT Inc.
    Contact Name
    Franz Menean
    Address
    264 Lafayette Rd Ste 7
    City
    Portsmouth
    State
    NH
    ZIP
    03801
    Country
    US
    Email
    [email protected]
    Phone
    603 5702039

    Products

    Device Name Product Code
    Apparatus, Autotransfusion CAC

    Proprietary Names

    XTRA Autotransfusion Cell Separator PROCEDURE SET TX/175 COLLECTION SET TX BOWL SET X/175 PROCEDURE SET BX/55 BOWL SET X/125 COLLECTION SET TX CARDIO BOWL SET X/225 XRES T with preconnected cardio kit PROCEDURE SET TX/55 COLLECTION SET BX CARDIO PROCEDURE SET BX/225 PROCEDURE SET BX/125 PROCEDURE SET TX/125 COLLECTION SET BX BOWL SET X/55 SEQUESTRATION SET X PROCEDURE SET TX/225 PROCEDURE SET BX/175 LINEA ASPIRAZIONE XTRA

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)