BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Precision II Implant

    DI: 08809468051355 · Model: IWSS4808 · EBI Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Precision II Implant
    Primary DI
    08809468051355
    Version / Model
    IWSS4808
    Company Name
    EBI Inc.
    Labeler DUNS
    689515003
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-10-02
    Public Version
    1
    Public Version Date
    2025-10-10
    Public Version Status
    New
    Public Device Record Key
    9417dafa-ff9b-4fe4-a1c2-e00dc22e43ad

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

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DZE Implant, Endosseous, Root-Form

    GMDN Terms

    Code Name
    55848 Screw endosteal dental implant, one-piece

    Identifiers

    Type ID
    Primary 08809468051355