BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Scholten Novatome, 6 French x 50cm, SU104-50

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    2029275
    FEI Number
    1000306431
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    344 Bonnie Cir
    City
    Corona
    State
    CA
    ZIP
    92878
    Country
    US

    Regulatory Submissions

    510(k) Number
    K072051

    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
    Device, Biopsy, Endomyocardial DWZ

    Proprietary Names

    Scholten Novatome, 6 French x 50cm, SU104-50 Scholten Novatome, 7 French x 50cm, SU103-50 Scholten Novatome, 7 French x 100cm, SU103-100 Scholten Novatome, 9 French x 50cm, SU101-50 Scholten Novatome, 8 French x 50cm, SU102-50 Scholten Novatome, 6 French x 100cm, SU104-100 Scholten Novatome, 7 French x 100cm, SU103-100PC Scholten Novatome, 9 French x 50cm Scholten Novatome, 6 French x 100cm Scholten Novatome, 8 French x 50cm Scholten Novatome, 6 French x 50cm Scholten Novatome, 7 French x 50cm Scholten Novatome, 8 French x 100cm Scholten Novatome, 7 French x 100cm Scholten Novatome, 9 French x 100cm

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)