BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DSS HP Polyaxial pedicle screw set, Ø6 x 55mm

    DI: 04260148897016 · Model: HPI86055 · Paradigm Spine GmbH
    View on AccessGUDID
    Product Codes
    4
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DSS HP Polyaxial pedicle screw set, Ø6 x 55mm
    Primary DI
    04260148897016
    Version / Model
    HPI86055
    Company Name
    Paradigm Spine GmbH
    Labeler DUNS
    537619731
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-10-01
    Public Version
    4
    Public Version Date
    2021-06-10
    Public Version Status
    Update
    Public Device Record Key
    03c74eb2-fc27-4ce9-b1c6-c35fbae250f7

    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
    NQP Posterior Metal/Polymer Spinal System, Fusion
    NKB Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
    MNI Orthosis, Spinal Pedicle Fixation
    MNH Orthosis, Spondylolisthesis Spinal Fixation

    GMDN Terms

    Code Name
    58446 Spinal dynamic-stabilization system

    Identifiers

    Type ID
    Primary 04260148897016