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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Stryker Universal Select Sterilization Tray System

    DI: 00857387006299 · Model: 29-20903 · PARAGON MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Stryker Universal Select Sterilization Tray System
    Primary DI
    00857387006299
    Version / Model
    29-20903
    Company Name
    PARAGON MEDICAL, INC.
    Labeler DUNS
    609244454
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-04-24
    Public Version
    7
    Public Version Date
    2023-10-02
    Public Version Status
    Update
    Public Device Record Key
    c88b8f06-7705-4065-99a8-565d2ac484bf

    Device Description

    2.0 MP Plates/Screws Module

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

    GMDN Terms

    Code Name
    12143 Instrument tray, reusable

    Identifiers

    Type ID
    Primary 00857387006299

    Customer Contacts

    Phone
    1-800-225-6975
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K173615 000