BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tensor Surgical

    DI: 00850019153002 · Model: 3000 · TENSOR SURGICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    2

    Basic Information

    Brand Name
    Tensor Surgical
    Primary DI
    00850019153002
    Version / Model
    3000
    Catalog Number
    3000
    Company Name
    TENSOR SURGICAL, INC.
    Labeler DUNS
    051885419
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2020-06-09
    Public Version
    2
    Public Version Date
    2022-06-17
    Public Version Status
    Update
    Public Device Record Key
    64af0ca7-c171-4b20-abf4-4322983ee917

    Device Description

    Reusable devices used as a kit to shuttle suture through bone

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    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
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    LXH Orthopedic Manual Surgical Instrument

    GMDN Terms

    Code Name
    44058 General surgical procedure kit, non-medicated, reusable

    Identifiers

    Type ID
    Primary 00850019153002
    Unit of Use 00850019153088