BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SuperCable® ISO-Elastic™ Cerclage System

    DI: 00818720011332 · Model: 38-800-3400 · Kinamed, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SuperCable® ISO-Elastic™ Cerclage System
    Primary DI
    00818720011332
    Version / Model
    38-800-3400
    Catalog Number
    38-800-3400
    Company Name
    Kinamed, Inc.
    Labeler DUNS
    184896645
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-21
    Public Version
    1
    Public Version Date
    2023-06-29
    Public Version Status
    New
    Public Device Record Key
    2d656d23-42c3-4d53-bacb-f4e946d3d57c

    Device Description

    Curved Mini Passer (For use with 1.5mm SuperCable Implant)

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LXH Orthopedic Manual Surgical Instrument

    GMDN Terms

    Code Name
    44054 Orthopaedic surgical procedure kit, non-medicated, reusable

    Identifiers

    Type ID
    Primary 00818720011332