BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SURGICAL INSTRUMENT

    DI: 07899995294708 · Model: LSDGD 3813 · Sin Sistema de Implante Nacional S/A
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SURGICAL INSTRUMENT
    Primary DI
    07899995294708
    Version / Model
    LSDGD 3813
    Catalog Number
    LSDGD 3813
    Company Name
    Sin Sistema de Implante Nacional S/A
    Labeler DUNS
    904569092
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-03-25
    Public Version
    1
    Public Version Date
    2021-04-02
    Public Version Status
    New
    Public Device Record Key
    e135d76a-ed0b-4621-aca9-24a10c4f6f86

    Device Description

    SAFE DRILL STOPPER GUIDE Ø3,8/Ø4,25x13MM

    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
    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
    KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

    GMDN Terms

    Code Name
    45714 Fixture/appliance dental drill bit, reusable

    Identifiers

    Type ID
    Primary 07899995294708

    Premarket Submissions

    Submission Number Supplement Number
    K201688 000