BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FLYTE SURGICOOL TOGA, PULLOVER, XL

    Reg #: 1721686 · FEI: 1721686 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    1721686
    FEI Number
    1721686
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2400 Airport Rd
    City
    Santa Teresa
    State
    NM
    ZIP
    88008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141095

    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
    Gown, Surgical FYA

    Proprietary Names

    FLYTE SURGICOOL TOGA, PULLOVER, XL FLYTE SURGICOOL TOGA, Zipper PEELAWAY, L FLYTE SURGICOOL TOGA, PULLOVER, 2X FLYTE SURGICOOL TOGA, ZIPPER, 2X FLYTE SURGICOOL TOGA, PULLOVER, L FLYTE SURGICOOL TOGA, PEELAWAY FLYTE SURGICOOL TOGA, PULLOVER, 3X FLYTE SURGICOOL TOGA, PEELAWAY, 2X FLYTE TOGA, PULLOVER XL FLYTE SURGICOOL TOGA, ZIPPER, L FLYTE SURGICOOL TOGA, PEELAWAY, 3X FLYTE SURGICOOL TOGA, ZIPPER FLYTE SURGICOOL TOGA, ZIPPER 3X

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)