BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RF CANNULATED DEPTH GAUGE

    Reg #: 1833986 · FEI: 1000139987 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    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
    K101622

    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
    Rod, Fixation, Intramedullary And Accessories HSB

    Proprietary Names

    RF CANNULATED DEPTH GAUGE RETRO FEM NUT COUNTERBORE RF CALIBRATED DRILL 4.9MM RF DRILL SLEEVE 4.9MM RF DRILL SLEEVE 4.3MM RF TAPER REAMER 13.5MM RF MOD 3.5MM HEX SCREWDRIVER RF GUIDE PIN SLEEVE 3MM RF CANN EXTRCTN ADAPTER 5/16IN RF CORTICAL NUT DRIVER

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)