BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ELEOS™

    DI: B278MS060MM02M0 · Model: MS-060MM-02M · ONKOS SURGICAL, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ELEOS™
    Primary DI
    B278MS060MM02M0
    Version / Model
    MS-060MM-02M
    Catalog Number
    MS-060MM-02M
    Company Name
    ONKOS SURGICAL, INC.
    Labeler DUNS
    080254074
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-07-21
    Public Version
    2
    Public Version Date
    2022-05-25
    Public Version Status
    Update
    Public Device Record Key
    4df32380-8c2e-42ad-a586-920adc349b65

    Device Description

    ELEOS™ MALE-MALE MIDSECTION 60MM

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Radiation Sterilization

    Product Codes

    Code Name
    JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented
    KRO PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

    GMDN Terms

    Code Name
    61561 Body femoral/tibial extension stem, uncoated

    Identifiers

    Type ID
    Primary B278MS060MM02M0

    Customer Contacts

    Phone
    +1(844)767-2766
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K161520 000