BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Pedicle Awl XL

    DI: 07290115934731 · Model: 87148 · PREMIA SPINE LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Pedicle Awl XL
    Primary DI
    07290115934731
    Version / Model
    87148
    Company Name
    PREMIA SPINE LTD
    Labeler DUNS
    649220779
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-09-03
    Public Version
    2
    Public Version Date
    2025-09-17
    Public Version Status
    Update
    Public Device Record Key
    5cede2d7-f9b7-4f94-bf49-9d4a7d5c4731

    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
    QWK Prosthesis, Posterior Spinal Elements

    GMDN Terms

    Code Name
    15275 Bone awl, reusable

    Identifiers

    Type ID
    Primary 07290115934731