BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    545050501 SmartSet GMV Gentamicin Bone Cement

    Reg #: 3008132398 · FEI: 3002807091 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Sterigenics UK Limited
    Registration Number
    3008132398
    FEI Number
    3002807091
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Cotes Park Lane, Somercotes
    City
    Alfreton Derbyshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K081163

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Bone Cement, Antibiotic MBB
    Bone Cement LOD

    Proprietary Names

    545050501 SmartSet GMV Gentamicin Bone Cement 545050500 SmartSet GMV Endurance Gentamicin Bone Cement 40g SmartSet GMV Gentamicin Bone Cement

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)