BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PLS

    DI: G463066442B0 · Model: 06.6442B · BOXSPINE HOLDINGS, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PLS
    Primary DI
    G463066442B0
    Version / Model
    06.6442B
    Catalog Number
    06.6442B
    Company Name
    BOXSPINE HOLDINGS, INC.
    Labeler DUNS
    126547906
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-06-12
    Public Version
    1
    Public Version Date
    2025-06-20
    Public Version Status
    New
    Public Device Record Key
    303a4ba0-f6f4-4f8c-917d-436a31564c07

    Device Description

    Rod, Curved, Ti-6Al-4V, Ø5.5 X 120mm (YELLOW)

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NKB Thoracolumbosacral Pedicle Screw System
    KWP Appliance, Fixation, Spinal Interlaminal

    GMDN Terms

    Code Name
    65116 Bone-screw internal spinal fixation system rod

    Identifiers

    Type ID
    Primary G463066442B0