BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    GLOBAL UNITE COLLAR SZ 56 ECC

    Reg #: 3008812251 · FEI: 3002808293 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    22
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Swann-Morton(Services) Limited
    Registration Number
    3008812251
    FEI Number
    3002808293
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Penn Works
    City
    Owlerton Green Sheffield
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K170748

    Owner / Operator

    Firm Name
    SWANN MORTON, LTD.
    Operator Number
    9003320
    Address
    OWLERTON GREEN, --
    City
    SHEFFIELD
    State
    GB-NOTA
    Postal Code
    --
    Country
    GB

    US Agent

    Business Name
    REGULATORY INSIGHT, INC.
    Contact Name
    KEVIN WALLS
    Address
    33 Golden Eagle Lane
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Shoulder Prosthesis, Reverse Configuration PHX

    Proprietary Names

    GLOBAL UNITE COLLAR SZ 56 ECC GLOBAL UNITE BODY SZ 14 -5 GLOBAL UNITE COLLAR SZ 52 GLOBAL UNITE BODY SZ 12 +5 GLOBAL UNITE COLLAR SZ 52 ECC GLOBAL UNITE BODY SZ 16 -5 GLOBAL UNITE BODY 16 +5 GLOBAL UNITE BODY SZ 12 0 GLOBAL UNITE BODY SZ 10 -5 GLOBAL UNITE BODY SZ 14 0 GLOBAL UNITE COLLAR SZ 44 ECC GLOBAL UNITE COLLAR SZ 48 ECC GLOBAL UNITE BODY SZ 10 0 GLOBAL UNITE BODY SZ 14 +5 GLOBAL UNITE COLLAR SZ 44 GLOBAL UNITE COLLAR SZ 40 GLOBAL UNITE COLLAR SZ 56 GLOBAL UNITE COLLAR SZ 48 GLOBAL UNITE BODY SZ 16 0 GLOBAL UNITE COLLAR SZ 40 ECC GLOBAL UNITE BODY SZ 10 +5 GLOBAL UNITE BODY SZ 12 -5

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)