BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SET ZZ BASE ST-SO-WSM RN 4.8

    DI: D800ZBCD0632 · Model: ZBCD0632 · ZIRKONZAHN SRL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SET ZZ BASE ST-SO-WSM RN 4.8
    Primary DI
    D800ZBCD0632
    Version / Model
    ZBCD0632
    Company Name
    ZIRKONZAHN SRL
    Labeler DUNS
    564251911
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-24
    Public Version
    1
    Public Version Date
    2020-10-02
    Public Version Status
    New
    Public Device Record Key
    8697ff75-f5d1-497f-880d-5b925319b483

    Device Description

    SET ZZ BASE ST-SO-WSM RN 4.8 (White Scanmarker and screw). The ZZ BASE WSM (WHITE SCANMARKER) allows the user to record the implant position and inclination in the patient’s mouth or on the model.

    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
    Yes
    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
    NDP Accessories, Implant, Dental, Endosseous

    GMDN Terms

    Code Name
    61641 Dental implant abutment analog, scanning

    Identifiers

    Type ID
    Primary D800ZBCD0632