BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Shofu Block HC

    DI: E2352169B9 · Model: 2169B · SHOFU DENTAL CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    Shofu Block HC
    Primary DI
    E2352169B9
    Version / Model
    2169B
    Catalog Number
    2169B
    Company Name
    SHOFU DENTAL CORPORATION
    Labeler DUNS
    054618202
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    4
    Public Version Date
    2023-04-04
    Public Version Status
    Update
    Public Device Record Key
    7f58b628-fdad-4aac-8cfc-0fb65c1f5892

    Device Description

    SHOFU BLOCK HC M A2-HT (10 PCS)

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EBF Material, Tooth Shade, Resin

    GMDN Terms

    Code Name
    38597 Dental milling system, CAD/CAM, chairside

    Identifiers

    Type ID
    Primary E2352169B9
    Unit of Use E2352169B1

    Customer Contacts

    Phone
    760-566-3528
    Email
    [email protected]