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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Beyer Double Action Rongeur 18cm

    DI: G25012040180 · Model: 12-040-18 · N S SURGICAL COMPANY
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Beyer Double Action Rongeur 18cm
    Primary DI
    G25012040180
    Version / Model
    12-040-18
    Catalog Number
    12-040-18
    Company Name
    N S SURGICAL COMPANY
    Labeler DUNS
    645681649
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-03-28
    Public Version
    1
    Public Version Date
    2023-04-05
    Public Version Status
    New
    Public Device Record Key
    d9edd88c-cbb9-4a3d-8126-c3127ca146f3

    Device Description

    A hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. This is a reusable device.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Ethylene Oxide, Moist Heat or Steam Sterilization, Ultraviolet Light

    Product Codes

    Code Name
    HTX Rongeur

    GMDN Terms

    Code Name
    32853 Orthopaedic joint/limb rongeur

    Identifiers

    Type ID
    Primary G25012040180

    Device Sizes

    Type Value Unit Text
    Length 18 Centimeter