BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TORO, MEDIUM AXIAL, 3.5mm HEX

    DI: 00810019933066 · Model: 804-06-009 · Bradshaw Medical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    TORO, MEDIUM AXIAL, 3.5mm HEX
    Primary DI
    00810019933066
    Version / Model
    804-06-009
    Company Name
    Bradshaw Medical, Inc.
    Labeler DUNS
    621830582
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-02-06
    Public Version
    1
    Public Version Date
    2025-02-14
    Public Version Status
    New
    Public Device Record Key
    aca16fd8-7d5f-4c70-bc53-64e434d4c25c

    Device Description

    A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

    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
    Yes
    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
    Dry Heat Sterilization

    Product Codes

    Code Name
    HWR Driver, Prosthesis

    GMDN Terms

    Code Name
    33968 Surgical screwdriver, reusable

    Identifiers

    Type ID
    Primary 00810019933066