BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Real Intelligence

    DI: 00885556775271 · Model: ROB10067 · Smith & Nephew, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Real Intelligence
    Primary DI
    00885556775271
    Version / Model
    ROB10067
    Catalog Number
    ROB10067
    Company Name
    Smith & Nephew, Inc.
    Labeler DUNS
    045483575
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-07-01
    Public Version
    6
    Public Version Date
    2023-09-07
    Public Version Status
    Update
    Public Device Record Key
    c768f65f-95fa-434b-8b07-ed44905e11cb

    Device Description

    JOURNEY II TKA OPTIONS MODULE

    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    OLO Orthopedic stereotaxic instrument

    GMDN Terms

    Code Name
    12143 Instrument tray, reusable

    Identifiers

    Type ID
    Primary 00885556775271

    Customer Contacts

    Phone
    +1(800)238-7538
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K201022 000