BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    3DSRW Software

    DI: 03701311500445 · Model: L00016 · ECENTIAL ROBOTICS
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    3DSRW Software
    Primary DI
    03701311500445
    Version / Model
    L00016
    Company Name
    ECENTIAL ROBOTICS
    Labeler DUNS
    261610964
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-03-01
    Public Version
    2
    Public Version Date
    2023-08-31
    Public Version Status
    Update
    Public Device Record Key
    cc71e4bb-9000-4ee2-82d1-07613279b0bf

    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
    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
    42895 Robotic surgical navigation system application software

    Identifiers

    Type ID
    Primary 03701311500445

    Customer Contacts

    Phone
    +33458005520
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K221028 000
    K231886 000