BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TREPHINE DRILL INTERNAL Ø 5,7 MM, L: 8 MM FOR IMPLANT EXTRACTION KIT

    DI: 08435389816089 · Model: FTEX57-8 · BIOTECHNOLOGY INSTITUTE SL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TREPHINE DRILL INTERNAL Ø 5,7 MM, L: 8 MM FOR IMPLANT EXTRACTION KIT
    Primary DI
    08435389816089
    Version / Model
    FTEX57-8
    Company Name
    BIOTECHNOLOGY INSTITUTE SL
    Labeler DUNS
    461665312
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-11-22
    Public Version
    1
    Public Version Date
    2022-11-30
    Public Version Status
    New
    Public Device Record Key
    5bec1ed6-d31e-4db1-836a-32e7f85121a0

    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
    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
    EJL Bur, Dental

    GMDN Terms

    Code Name
    14147 Bone trephine

    Identifiers

    Type ID
    Primary 08435389816089