BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Spurling Pitutiary Ronguer 4mm/18cm

    DI: G25008007180 · Model: 08-007-18 · 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
    Spurling Pitutiary Ronguer 4mm/18cm
    Primary DI
    G25008007180
    Version / Model
    08-007-18
    Catalog Number
    08-007-18
    Company Name
    N S SURGICAL COMPANY
    Labeler DUNS
    645681649
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-09-02
    Public Version
    1
    Public Version Date
    2023-09-11
    Public Version Status
    New
    Public Device Record Key
    041172ae-dadf-4e6a-9253-a513266ce7dc

    Device Description

    A hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. This is a reusable device.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    Yes
    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
    Ultraviolet Light, Ethylene Oxide, Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    HTX Rongeur

    GMDN Terms

    Code Name
    35541 Spinal rongeur

    Identifiers

    Type ID
    Primary G25008007180

    Device Sizes

    Type Value Unit Text
    Length 18 Centimeter