BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SOLUTION SYSTEM

    DI: 10603295060741 · Model: 1571-13-000 · DEPUY ORTHOPAEDICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SOLUTION SYSTEM
    Primary DI
    10603295060741
    Version / Model
    1571-13-000
    Catalog Number
    157113000
    Company Name
    DEPUY ORTHOPAEDICS, INC.
    Labeler DUNS
    080506581
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-09-24
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    17a255fa-e396-49d4-b834-50847b31aecd

    Device Description

    SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER HIP STEM W/ POROCOAT 8 Inches 12.5mm STD

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

    GMDN Terms

    Code Name
    34191 Coated femoral stem prosthesis, modular

    Identifiers

    Type ID
    Primary 10603295060741

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K953703 000