BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CS-Pro MED

    DI: 00860014430503 · Model: CS-Pro MED · CURATIVE SOUND, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CS-Pro MED
    Primary DI
    00860014430503
    Version / Model
    CS-Pro MED
    Company Name
    CURATIVE SOUND, LLC
    Labeler DUNS
    108756583
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-01-02
    Public Version
    1
    Public Version Date
    2026-01-12
    Public Version Status
    New
    Public Device Record Key
    f0d425d4-5220-4256-9b0f-775207d8c69e

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

    GMDN Terms

    Code Name
    67673 Multidisciplinary extracorporeal shock wave therapy system, hand-held

    Identifiers

    Type ID
    Primary 00860014430503

    Premarket Submissions

    Submission Number Supplement Number
    K250779 000