BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Perfix™ Iliac Screw System

    DI: 08800015952590 · Model: SL0050 · Innosys Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Perfix™ Iliac Screw System
    Primary DI
    08800015952590
    Version / Model
    SL0050
    Company Name
    Innosys Co., Ltd.
    Labeler DUNS
    688811082
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-11-02
    Public Version
    4
    Public Version Date
    2023-06-19
    Public Version Status
    Update
    Public Device Record Key
    a2473f75-b311-4b9b-8814-2f850f8ab0c0

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    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
    Yes
    Has Serial Number
    Yes
    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
    HTJ GAUGE, DEPTH

    GMDN Terms

    Code Name
    35788 Orthopaedic bone calliper

    Identifiers

    Type ID
    Primary 08800015952590

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Store in a cool dry place.