BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DIRECTscan™ Adapter Kit - Complete

    DI: 05904890607019 · Model: DS-Kit · APOLLO IMPLANT COMPONENTS SP Z O O
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DIRECTscan™ Adapter Kit - Complete
    Primary DI
    05904890607019
    Version / Model
    DS-Kit
    Company Name
    APOLLO IMPLANT COMPONENTS SP Z O O
    Labeler DUNS
    439457408
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-03-04
    Public Version
    1
    Public Version Date
    2026-03-12
    Public Version Status
    New
    Public Device Record Key
    c1d93c6d-d40e-4a8c-949a-799df7771ed1

    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
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    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, intraoral-scanning, single-use

    Identifiers

    Type ID
    Primary 05904890607019