BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    implacross® E PE insert 0 4mm offset ID = 02353648

    Reg #: 3002808022 · FEI: 3002808022 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    28
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ROSE GMBH FUER MEDIZINTECHNIK
    Registration Number
    3002808022
    FEI Number
    3002808022
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Gottbillstrasse 25
    City
    Trier Rhineland-Palatinate
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K203420

    Owner / Operator

    Firm Name
    Rose GmbH fuer Medizintechnik
    Operator Number
    10042910
    Address
    Gottbillstrasse 25
    City
    Trier
    State
    Rhineland-Palatinate
    Postal Code
    54294
    Country
    DE
    Correspondent
    Thomas Rose

    US Agent

    Business Name
    German American Chamber of Commerce, Inc.
    Contact Name
    German American Chamber of Commerce, Inc. German American Ch
    Address
    80 Pine Street, 24th Floor
    City
    New York
    State
    NY
    ZIP
    10005
    Country
    US
    Email
    [email protected]
    Phone
    212 9748830

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO

    Proprietary Names

    implacross® E PE insert 0 4mm offset ID = 02353648 implacross® E PE insert 15 ID = 02373248 implacross® E PE insert 10 4mm offset ID = 02363244 implacross® E PE insert 0 4mm offset ID = 02353644 implacross® E PE insert 0 4mm offset ID = 02353252 implacross® E PE insert 15 4mm offset ID = 02483652 implacross® E PE insert 10 4mm offset ID = 02363239 implacross® E PE insert 0 4mm offset ID = 02353239 implacross® E PE insert 15 ID = 02373648 implacross® E PE insert 15 4mm offset ID = 02483644 implacross® E PE insert 15 ID = 02373652 implacross® E PE insert 15 4mm offset ID = 02483648 implacross® E PE insert 0 4mm offset ID = 02353248 implacross® E PE insert 15 ID = 02373644 implacross® E PE insert 10 4mm offset ID = 02363252 implacross® E PE insert 15 4mm offset ID = 02483239 implacross® E PE insert 10 4mm offset ID = 02363644 implacross® E PE insert 10 4mm offset ID = 02363648 implacross® E PE insert 10 4mm offset ID = 02363248 implacross® E PE insert 15 4mm offset ID = 02483244 implacross® E PE insert 15 4mm offset ID = 02483252 implacross® E PE insert 15 4mm offset ID = 02483248 implacross® E PE insert 15 ID = 02373244 implacross® E PE insert 15 ID = 02373252 implacross® E PE insert 0 4mm offset ID = 02353652 implacross® E PE insert 15 ID = 02373239 implacross® E PE insert 10 4mm offset ID = 02363652 implacross® E PE insert 0 4mm offset ID = 02353244

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)