BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ROI

    DI: 03662663041669 · Model: IR919R · LDR Spine Usa, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    ROI
    Primary DI
    03662663041669
    Version / Model
    IR919R
    Catalog Number
    IR919R
    Company Name
    LDR Spine Usa, Inc.
    Labeler DUNS
    615789729
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-12-12
    Public Version
    5
    Public Version Date
    2025-01-03
    Public Version Status
    Update
    Public Device Record Key
    46d7b720-8f68-47ad-9242-2cf0e3f7384a

    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
    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
    NKB Thoracolumbosacral Pedicle Screw System

    GMDN Terms

    Code Name
    47829 Surgical instrument handle, non-torque-limiting

    Identifiers

    Type ID
    Primary 03662663041669

    Customer Contacts

    Phone
    800-699-3360
    Email
    [email protected]