BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ultrablator

    Reg #: 1058584 · FEI: 1000219637 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    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
    K030720

    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
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    Ultrablator ULTRABLATOR 90 DEGREE, THREE RIB, 110MM LENGTH, 3.2MM DIAMETER, QTY 5 ULTRABLATOR 30 DEGREE, 110MM LENGTH, 2.5MM DIAMETER, QTY 5 ULTRABLATOR 90 DEGREE, THREE RIB, 130MM LENGTH, 3.2MM DIAMETER, QTY 5 ULTRABLATOR 90 DEGREE, 110MM LENGTH, 2.5MM DIAMETER, QTY 5 ULTRABLATOR 30 DEGREE, THREE RIB, 130MM LENGTH, 3.2MM DIAMETER, QTY 5 ULTRABLATOR 30 DEGREE, THREE RIB, 110MM LENGTH, 3.2MM DIAMETER, QTY 5 ULTRABLATOR 30 DEGREE, 110MM LENGTH, 3.2MM DIAMETER, QTY 5 ULTRABLATOR 90 DEGREE, 110MM LENGTH, 3.2MM DIAMETER, QTY 5 ULTRABLATOR 30 DEGREE, 60MM LENGTH, 2.5MM DIAMETER, QTY 5

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)