BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Reverse Inserts - inclined 20 - cPE / 643-036/20

    Reg #: 3002808022 · FEI: 3002808022 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    54
    Establishment Types
    1
    Classifications
    3

    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
    K200368

    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
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented PAO
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD

    Proprietary Names

    Reverse Inserts - inclined 20 - cPE / 643-036/20 Reverse Inserts - cPE / 643-036/06 Reverse Inserts - inclined 10 - cPE / 643-039/13 Reverse Inserts - inclined 20 - E-Dur / 643-239/23 Reverse Inserts - inclined 10 - E-Dur / 643-242/16 Reverse Inserts - cPE / 643-039/03 Reverse Inserts - inclined 20 - E-Dur / 643-242/20 Reverse Inserts - inclined 20 - cPE / 643-039/26 Reverse Inserts - inclined 10 - cPE / 643-042/10 Reverse Inserts - E-Dur / 643-242/06 Reverse Inserts - inclined 10 - E-Dur / 643-239/13 Reverse Inserts - cPE / 643-039/06 Reverse Inserts - inclined 20 - cPE / 643-039/23 Reverse Inserts - inclined 20 - E-Dur / 643-242/26 Reverse Inserts - inclined 10 - E-Dur / 643-239/16 Reverse Inserts - inclined 10 - cPE / 643-039/16 Reverse Inserts - E-Dur / 643-242/03 Reverse Inserts - E-Dur / 643-236/00 Reverse Inserts - inclined 20 - cPE / 643-042/23 Reverse Inserts - inclined 20 - E-Dur / 643-236/20 Reverse Inserts - cPE / 643-042/00 Reverse Inserts - inclined 20 - cPE / 643-039/20 Reverse Inserts - inclined 10 - cPE / 643-036/13 Reverse Inserts - inclined 10 - cPE / 643-039/10 Reverse Inserts - inclined 10 - E-Dur / 643-242/13 Reverse Inserts - inclined 10 - cPE / 643-036/16 Reverse Inserts - inclined 20 - E-Dur / 643-236/26 Reverse Inserts - cPE / 643-039/00 Reverse Inserts - E-Dur / 643-236/03 Reverse Inserts - inclined 10 - cPE / 643-042/16 Reverse Inserts - E-Dur / 643-239/00 Reverse Inserts - inclined 20 - cPE / 643-036/26 Reverse Inserts - inclined 20 - cPE / 643-036/23 Reverse Inserts - inclined 20 - E-Dur / 643-239/20 Reverse Inserts - E-Dur / 643-239/03 Reverse Inserts - cPE / 643-042/03 Reverse Inserts - inclined 20 - E-Dur / 643-242/23 Reverse Inserts - inclined 20 - cPE / 643-042/20 Reverse Inserts - inclined 10 - cPE / 643-036/10 Reverse Inserts - E-Dur / 643-239/06 Reverse Inserts - inclined 10 - E-Dur / 643-236/13 Reverse Inserts - cPE / 643-036/03 Reverse Inserts - inclined 20 - cPE / 643-042/26 Reverse Inserts - inclined 10 - E-Dur / 643-236/10 Reverse Inserts - E-Dur / 643-236/06 Reverse Inserts - E-Dur / 643-242/00 Reverse Inserts - inclined 10 - cPE / 643-042/13 Reverse Inserts - inclined 10 - E-Dur / 643-239/10 Reverse Inserts - inclined 10 - E-Dur / 643-236/16 Reverse Inserts - cPE / 643-042/06 Reverse Inserts - inclined 20 - E-Dur / 643-236/23 Reverse Inserts - inclined 20 - E-Dur / 643-239/26 Reverse Inserts - inclined 10 - E-Dur / 643-242/10 Reverse Inserts - cPE / 643-036/00

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)