BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DTRAX® Spinal System-L

    DI: 00852776006188 · Model: DX-22-600 · PROVIDENCE MEDICAL TECHNOLOGY, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DTRAX® Spinal System-L
    Primary DI
    00852776006188
    Version / Model
    DX-22-600
    Catalog Number
    DX-22-600
    Company Name
    PROVIDENCE MEDICAL TECHNOLOGY, INC.
    Labeler DUNS
    969820245
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-12
    Public Version
    5
    Public Version Date
    2019-06-07
    Public Version Status
    Update
    Public Device Record Key
    f78fb550-ed1f-4522-a5d7-ff1ee90af710

    Device Description

    A set of individual non-powered, disposable, hand-held surgical instruments intended and indicated for preparation of a spinal joint to aid in fusion. The set contains trial spacers, an awl, and a screwdriver.

    Device Characteristics

    Single Use
    Yes
    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Radiation Sterilization

    Product Codes

    Code Name
    LXH Orthopedic Manual Surgical Instrument

    GMDN Terms

    Code Name
    61300 Internal spinal fixation procedure kit, single-use

    Identifiers

    Type ID
    Package 10852776006185
    Primary 00852776006188