BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    545050501 SmartSet GMV Gentamicin Bone Cement

    Reg #: 3005941719 · FEI: 3002807111 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Sterigenics Belgium Petit Rechain S.A.
    Registration Number
    3005941719
    FEI Number
    3002807111
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Zoning Industriel de Petit-Rechain, Avenue Andre Ernst 21
    City
    Verviers Liege
    Country
    BE

    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)