BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Osstell IDx Instrument

    DI: 09010522000892 · Model: Osstell Osstell IDx Instrument · Osstell AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Osstell IDx Instrument
    Primary DI
    09010522000892
    Version / Model
    Osstell Osstell IDx Instrument
    Catalog Number
    100591
    Company Name
    Osstell AB
    Labeler DUNS
    633171269
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-11-01
    Public Version
    1
    Public Version Date
    2022-11-09
    Public Version Status
    New
    Public Device Record Key
    bb2424c6-fee3-4a7d-821d-305a44058ced

    Device Description

    ISQ Measurement Instrument

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EKX Handpiece, Direct Drive, Ac-Powered

    GMDN Terms

    Code Name
    63467 Dental implant stability measurement control unit

    Identifiers

    Type ID
    Package 09010522000847
    Primary 09010522000892
    Package 09010522000854