BEUDAMED
    FDA Registration Active 🇺🇸 United States

    6MM Fine Diamond

    Reg #: 1833986 · FEI: 1000139987 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    30
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PRECISION EDGE SURGICAL PRODUCTS COMPANY
    Registration Number
    1833986
    FEI Number
    1000139987
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    415 W 12th Ave
    City
    Sault Sainte Marie
    State
    MI
    ZIP
    49783
    Country
    US

    Regulatory Submissions

    510(k) Number
    K143320

    Owner / Operator

    Firm Name
    Precision Edge Surgical Products Company
    Operator Number
    10042577
    Address
    415 West 12th Avenue
    City
    Sault Sainte Marie
    State
    MI
    Postal Code
    49783
    Country
    US
    Correspondent
    Angela Gorsuch

    Products

    Device Name Product Code
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE

    Proprietary Names

    6MM Fine Diamond 3MM X-Coarse Diamond 1.5MM Fine Diamond 5MM Coarse Diamond 3MM Coarse Diamond, Extended 4.5MM Fine Diamond 5MM Fine Diamond 2.5MM Coarse Diamond 5MM X-Coarse Diamond 1MM Fine Diamond 3MM Fine Diamond 3MM Coarse Diamond 4MM X-Coarse Diamond, Extended 1MM Coarse Diamond 6MM Coarse Diamond 5MM X-Coarse Diamond, Extended 2MM Coarse Diamond 4MM Coarse Diamond 4MM Fine Diamond 4MM Fine Diamond, Short 5.5MM Fine Diamond 3.5MM X-Coarse Diamond 4MM X-Coarse Diamond 2MM Fine Diamond 3.5MM Fine Diamond 0.7MM Fine Diamond 0.5MM Fine Diamond 6MM X-Coarse Diamond 4.5MM XX-Coarse Diamond 1.5MM Coarse Diamond

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)