BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SUPER FLEX PLUG SINGLE PACK .4MM

    Reg #: 1649518 · FEI: 3001236277 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    32
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    1649518
    FEI Number
    3001236277
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3125 Wichita Court
    City
    Fort Worth
    State
    TX
    ZIP
    76140
    Country
    US

    Regulatory Submissions

    510(k) Number
    K991130

    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
    Plug, Punctum LZU

    Proprietary Names

    SUPER FLEX PLUG SINGLE PACK .4MM SUPER FLEX PLUG SINGLE PACK .3MM SUPER FLEX PLUG SINGLE PACK 1MM Punctum Plug PUNCTUM PLUG TS SINGLE .5MM SUPER FLEX PLUG SINGLE PACK 1.1MM EAGLE FLEX PLUG SINGLE PACK .5MM Punctum Plug SUPEREAGLE PLUG SINGLE PACK - MEDIUM,50A EAGLE FLEX PLUG SINGLE PACK .9MM SUPER FLEX PLUG SINGLE PACK 1.2MM Punctum Plug PUNCTUM PLUG TS SINGLE .7MM SUPER FLEX PLUG SINGLE PACK 1.3MM Punctum Plug PUNCTUM PLUG TS SINGLE .4MM EAGLE FLEX PLUG SINGLE PACK 1.1MM EAGLE FLEX PLUG SINGLE PACK .8MM SUPER FLEX PLUG SINGLE PACK .6MM Punctum Plug SUPEREAGLE PLUG SINGLE PACK - SMALL,50A Punctum Plug SUPEREAGLE PLUG SINGLE PACK - LARGE,50A SUPER FLEX PLUG SINGLE PACK .7MM SUPEREAGLE PLUG SINGLE PACK - SMALL,30A SUPEREAGLE PLUG SINGLE PACK - LARGE,30A EAGLE FLEX PLUG SINGLE PACK 1MM EAGLE FLEX PLUG SINGLE PACK .7MM SUPER FLEX PLUG SINGLE PACK .5MM Punctum Plug PUNCTUM PLUG TS SINGLE .6MM SUPER FLEX PLUG SINGLE PACK .8MM Punctum Plug PUNCTUM PLUG TS SINGLE .8MM SUPER FLEX PLUG SINGLE PACK .9MM EAGLE FLEX PLUG SINGLE PACK .4MM EAGLE FLEX PLUG SINGLE PACK .6MM SUPEREAGLE PLUG SINGLE PACK - EX LARGE,30A SUPEREAGLE PLUG SINGLE PACK - MEDIUM,30A Plug One

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)