BEUDAMED
    FDA Registration Active 🇺🇸 United States

    2.4 X 10mm MDI MAX WITH AN O-BALL HEAD

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    32
    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
    K031106

    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
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    2.4 X 10mm MDI MAX WITH AN O-BALL HEAD 2.1 X 10mm MDI COLLARED INTERMEDIATE O-BALL 2.1 X 15mm MDI COLLARED INTERMEDIATE O-BALL 2.4 X 18mm MDI MAX WITH AN O-BALL HEAD AND COLLAR 1.8 X 18mm MDI O-BALL PROSTHETIC HEAD 2.4 X 15mm MDI MAX WITH A SQUARE HEAD AND COLLAR 2.1 X 13mm MDI CLASSIC INTERMEDIATE O-BALL 2.1 X 18mm MDI CLASSIC INTERMEDIATE O-BALL 2.4 X 18mm MDI MAX WITH AN O-BALL HEAD 1.8 X 10mm MDI STANDARD O-BALL AND COLLAR 2.4 X 13mm MDI MAX WITH AN O-BALL HEAD 1.8 X 15mm MDI O-BALL PROSTHETIC HEAD 2.4 X 13mm MDI MAX WITH A SQUARE HEAD AND COLLAR 1.8 X 13 mm MDI O-BALL PROSTHETIC HEAD 2.4 X 18mm MDI MAX WITH A SQUARE HEAD AND COLLAR 1.8 X 15mm MDI STANDARD O-BALL AND COLLAR 2.4 X 10mm MDI MAX WITH AN O-BALL HEAD AND COLLAR 2.4 X 15mm MDI MAX WITH A STRAIGHT HEAD 2.4 X 15mm MDI MAX WITH AN O-BALL HEAD AND COLLAR 1.8 X 10mm MDI O-BALL PROSTHETIC HEAD 2.1 X 10mm MDI CLASSIC INTERMEDIATE O-BALL 1.8 X 18mm MDI STANDARD O-BALL AND COLLAR 1.8 X 18mm MDI STANDARD SQUARE HEAD AND COLLAR 2.4 X 10mm MDI MAX WITH A SQUARE HEAD AND COLLAR 2.1 X 18mm MDI COLLARED INTERMEDIATE O-BALL 1.8 X 10mm MDI STANDARD SQUARE HEAD AND COLLAR 1.8 X 13mm MDI STANDARD SQUARE HEAD AND COLLAR 1.8 X 15mm MDI STANDARD SQUARE HEAD AND COLLAR 2.4 X 13mm MDI MAX WITH AN O-BALL HEAD AND COLLAR 2.1 X 13mm MDI COLLARED INTERMEDIATE O-BALL 2.1 X 15mm MDI CLASSIC INTERMEDIATE O-BALL 1.8 X 13mm MDI STANDARD O-BALL AND COLLAR

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)