BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PIEZON MASTER SURGERY

    DI: 07613353029814 · Model: C · 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
    PIEZON MASTER SURGERY
    Primary DI
    07613353029814
    Version / Model
    C
    Catalog Number
    DS-103A
    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
    2016-09-08
    Public Version
    4
    Public Version Date
    2018-09-27
    Public Version Status
    Update
    Public Device Record Key
    1e7ca1f9-bcd5-4920-ab7b-faa5f27ec969

    Device Description

    Instrument SL3 with CT

    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    DZI Drill, Bone, Powered

    GMDN Terms

    Code Name
    47015 Dental ultrasonic surgical system handpiece tip

    Identifiers

    Type ID
    Primary 07613353029814

    Customer Contacts

    Phone
    +41229944700
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K072146 000