BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Swiss DolorClast

    DI: 07613353000042 · Model: EL-158 · E.M.S. Electro Medical Systems S.A.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Swiss DolorClast
    Primary DI
    07613353000042
    Version / Model
    EL-158
    Company Name
    E.M.S. Electro Medical Systems S.A.
    Labeler DUNS
    481233849
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-11-04
    Public Version
    5
    Public Version Date
    2018-09-24
    Public Version Status
    Update
    Public Device Record Key
    54486342-cd9b-4071-849c-f2381292a97f

    Device Description

    Applicator Ø15mm

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NBN Generator, Shock-Wave, For Pain Relief

    GMDN Terms

    Code Name
    47032 Pneumatic orthopaedic extracorporeal shock wave therapy system

    Identifiers

    Type ID
    Primary 07613353000042

    Customer Contacts

    Phone
    +41229944700
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    P050004 001