BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Kypho Pak Tray

    Reg #: 1423662 · FEI: 3000215273 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    1423662
    FEI Number
    3000215273
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1003 Lakeside Drive
    City
    Gurnee
    State
    IL
    ZIP
    60031
    Country
    US

    Regulatory Submissions

    510(k) Number
    K041454

    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
    Arthroscope HRX

    Proprietary Names

    Kypho Pak Tray Kyphon Balloon Kyphoplasty Essentials Kits Kyphon Xpander and Express Inflatable Bone Tamps KyphoPak Xpander and Express First Fracture and Additional Fracture Trays Balloon Kyphoplaty Essentials Kit KyphoPak™ Xpander Tray Kyphx Xpander Inflatable Bone Tamps

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)