BEUDAMED
    FDA Registration Active 🇺🇸 United States

    351.27S

    Reg #: 1058584 · FEI: 1000219637 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    21
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    1058584
    FEI Number
    1000219637
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10811 Withers Cove Park Drive
    City
    Charlotte
    State
    NC
    ZIP
    28278
    Country
    US

    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
    Reamer HTO

    Proprietary Names

    351.27S 35540S 35542S 351.716S 351.707S 351.709S 351.71S 351.715S 351.76S 355.399S 351.706S 351.708S 351.704S CONCEPT GRAFIX CORING REAMER 7MM, QTY 4 CONCEPT GRAFIX CORING REAMER 10MM, QTY 4 Coring Reamer CONCEPT GRAFIX CORING REAMER 9MM, QTY 4 CONCEPT GRAFIX CORING REAMER 8MM, QTY 4 CONCEPT GRAFIX CORING REAMER 11MM, QTY 4 Orthopedic Manual Surgical Instrument Sterile Coring Reamers

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)