BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ET Scan Body - Cerec

    DI: 00810019241734 · Model: ETCSB · HIOSSEN, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ET Scan Body - Cerec
    Primary DI
    00810019241734
    Version / Model
    ETCSB
    Company Name
    HIOSSEN, INC.
    Labeler DUNS
    796083090
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-05-15
    Public Version
    1
    Public Version Date
    2019-05-23
    Public Version Status
    New
    Public Device Record Key
    dec0c93d-5fba-4497-adba-372d2913c903

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    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
    NDP Accessories, Implant, Dental, Endosseous

    GMDN Terms

    Code Name
    44880 Dental implant suprastructure, temporary, preformed, single-use

    Identifiers

    Type ID
    Primary 00810019241734

    Premarket Submissions

    Submission Number Supplement Number
    K160519 000