BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Pedicle Screw Instruments Kit

    DI: B064XM11510001 · Model: XM-115-1000 · XENCO MEDICAL LLC
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Pedicle Screw Instruments Kit
    Primary DI
    B064XM11510001
    Version / Model
    XM-115-1000
    Company Name
    XENCO MEDICAL LLC
    Labeler DUNS
    079282130
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-08-11
    Public Version
    2
    Public Version Date
    2024-11-04
    Public Version Status
    Update
    Public Device Record Key
    5571e6de-27a7-474a-bbbf-d86120164db0

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    Sterilization Methods
    Radiation Sterilization

    GMDN Terms

    Code Name
    35559 Bone file/rasp, manual, reusable

    Identifiers

    Type ID
    Primary B064XM11510001