BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Osstell SmartPeg Mount

    DI: 09010522001158 · Model: Osstell SmartPeg Mount · Osstell AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Osstell SmartPeg Mount
    Primary DI
    09010522001158
    Version / Model
    Osstell SmartPeg Mount
    Catalog Number
    100345
    Company Name
    Osstell AB
    Labeler DUNS
    633171269
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-09-02
    Public Version
    1
    Public Version Date
    2022-09-12
    Public Version Status
    New
    Public Device Record Key
    65cef4fb-b59d-495f-86d0-0bf8eab5b175

    Device Description

    SmartPeg Mount

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    EKX Handpiece, Direct Drive, Ac-Powered

    GMDN Terms

    Code Name
    63467 Dental implant stability measurement control unit

    Identifiers

    Type ID
    Primary 09010522001158
    Package 09010522000014