BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Instrument

    DI: 05060296236007 · Model: MLE3 · Stanmore Implants Worldwide Ltd
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Instrument
    Primary DI
    05060296236007
    Version / Model
    MLE3
    Catalog Number
    JTS-DRIVE-UNIT
    Company Name
    Stanmore Implants Worldwide Ltd
    Labeler DUNS
    494989502
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-07-18
    Public Version
    2
    Public Version Date
    2023-06-05
    Public Version Status
    Update
    Public Device Record Key
    d50b13d7-7119-4a9c-93fc-bc1a22f931ce
    Distribution End Date
    2023-06-02

    Device Description

    JTS Drive Unit Set

    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
    Yes
    Has Lot/Batch Number
    No
    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
    KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

    GMDN Terms

    Code Name
    37655 Extremity MRI system, resistive magnet

    Identifiers

    Type ID
    Primary 05060296236007

    Premarket Submissions

    Submission Number Supplement Number
    K092138 000
    K133152 000