BEUDAMED
    FDA Registration Active 🇺🇸 United States

    K053321 Light, Surgical, Accessories

    Reg #: 1526534 · FEI: 1526534 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US, LLC
    Registration Number
    1526534
    FEI Number
    1526534
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    305 Enterprise Dr
    City
    Lewis Center
    State
    OH
    ZIP
    43035
    Country
    US

    Regulatory Submissions

    510(k) Number
    K053321

    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
    Light, Surgical, Accessories FTA

    Proprietary Names

    K053321 Light, Surgical, Accessories PILLING Light Handle Cover 1/pkg Medichoice Light Handle Cover Light Handle Cover 60513 3/pk 64 pk/case Sterile Semi-Rigid Light Cover 2/pack Light Handle Cover 2/pkg Semi-Rigid Light Handle Cover Medichoice Rigid Handle Rigid Light Handle 60881 1 ea 64/case Light Handle Cover 3/pkg Medichoice Rigid Handle (40 Packs of 2). Light Handle Rigid: 60882 Medichoice Light Handle Cover (80 Packs of 2). Light Handle: 60512 Light Guard Rigid 1/pkg Sterile Medichoice Light Handle Cvr Light Handle Cover 60511 1/pk 160/case Sterile Light Guard Rigid 2/pkg Sterile - (40 packs of 2)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)