BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    S-ROM

    DI: 10603295172802 · Model: 53-6318 · DEPUY ORTHOPAEDICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    S-ROM
    Primary DI
    10603295172802
    Version / Model
    53-6318
    Catalog Number
    536318
    Company Name
    DEPUY ORTHOPAEDICS, INC.
    Labeler DUNS
    080506581
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-24
    Public Version
    3
    Public Version Date
    2022-03-22
    Public Version Status
    Update
    Public Device Record Key
    de6d44a3-0c48-40f0-9995-387b858ce306

    Device Description

    S-ROM HIP STEM TRIAL BODY 18mm

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    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
    HWT TEMPLATE

    GMDN Terms

    Code Name
    58715 Knee femur prosthesis trial, reusable

    Identifiers

    Type ID
    Primary 10603295172802

    Customer Contacts

    Phone
    +1(800)255-2500
    Email
    [email protected]