BEUDAMED
    FDA Registration Active 🇺🇸 United States

    1847CV08SDF

    Reg #: 1058584 · FEI: 1000219637 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    84
    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

    Regulatory Submissions

    510(k) Number
    K183515

    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
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE

    Proprietary Names

    1847CV08SDF MR8-SP14BA30 MR8-SP12MH25 1847CV20LCT MR8-LP07BA10D MR8-ND13BA40DC MR8-LP05BA40DC MR8-LP05BA40D MR8-SP14MH25T MR8-SD12MH30 1847CV12SDF MR8-SD12BA40 MR8-ND13BA40 MR8-LP07BA30D MR8-LP05BA20 1847CV10LCT 1847CV20LDC 1847CV40LCT MR8-ND13MH30 MR8-SD12MH25 MR8-LP07BA30 MR8-ND13BA30DC MR8-LP05BA15 MR8-LP05BA20DC MR8-SP14MH30D MR8-SP14MH30T MR8-LP05BA30D MR8-LP07BA20DC MR8-SD12MH30D MR8-SD12MH25T 1847CV10SCT MR8-ND13BA30 MR8-LP05BA30 1847CV15SDF 1847CV20SDF MR8-SP12BA40 MR8-SP14MH30 1847CV30SDF MR8-SP12MH30D MR8-SP14BA40 MR8-SP12MH30 1847CV40LDC MR8-ND13MH30D MR8-SP14MH25 MR8-LP05BA20D 1847CV30LDC MR8-LP05BA10D 1847CV10LDF MR8-LP05BA12D MR8-LP05BA40 1847CV30LCT 1847CV30SCT 1847CV30LDF 1847CV20LDF MR8-SD12MH30T MR8-LP05BA30DC MR8-LP05BA05D MR8-SP12BA30 MR8-SP14MH25D MR8-LP07BA15 MR8-LP07BA20D MR8-SP12MH25D 1847CV05SDF MR8-SD12MH25D MR8-SP12MH30T MR8-LP07BA10 MR8-LP05BA08D MR8-LP07BA20 MR8-ND13BA45DC MR8-LP07BA40DC MR8-LP05BA10 MR8-SP12MH25T 1847CV30SDC 1847CV40LDF MR8-LP07BA40 MR8-LP05BA15D 1847CV15LCT 1847CV20SCT MR8-SD12BA30 MR8-LP07BA40D 1847CV20SDC 1847CV10SDF MR8-LP07BA30DC 1847CV15SCT

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)