BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tsolution One Surgical System

    DI: M9461027090 · Model: 102709 · THINK SURGICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Tsolution One Surgical System
    Primary DI
    M9461027090
    Version / Model
    102709
    Company Name
    THINK SURGICAL, INC.
    Labeler DUNS
    007211430
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    4
    Public Version Date
    2023-06-19
    Public Version Status
    Update
    Public Device Record Key
    767a8838-431a-43a1-9da1-df023895d7d6

    Device Description

    CUTTER DRIVER PROBE

    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
    Yes
    PM Exempt
    No
    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
    No

    Product Codes

    Code Name
    OLO Orthopedic stereotaxic instrument

    GMDN Terms

    Code Name
    38678 Robotic surgical arm system

    Identifiers

    Type ID
    Primary M9461027090

    Customer Contacts

    Phone
    +1(510)249-2323
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K153647 000