BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HyProCure Sizer 05

    Reg #: 3004993707 · FEI: 3004993707 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    21
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Graham Medical Technologies, L.L.C. d.b.a. GraMedica
    Registration Number
    3004993707
    FEI Number
    3004993707
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    16137 Leone Drive
    City
    Macomb
    State
    MI
    ZIP
    48042
    Country
    US

    Owner / Operator

    Firm Name
    GRAMEDICA
    Operator Number
    9069880
    Address
    16137 Leone Drive, --
    City
    Macomb
    State
    MI
    Postal Code
    48042
    Country
    US

    Products

    Device Name Product Code
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    HyProCure Sizer 05 HyProCure II Trial Sizer 12 Guide Wire osteo-WEDGE Depth Gauge HyProCure Sizer 07 HyProCure Sizer 10 HyProCure II Trial Sizer 08 HyProCure Sizer 09 HyProCure II Trial Sizer 06 HyProCure II Driver HyProCure II Trial Sizer 10 osteo-WEDGE Depth Gauge Sleeve HyProCure Driver osteo-WEDGE Screw Retainer Sleeve HyProCure II Positioning Sleeve osteo-WEDGE Driver HyProCure II Trial Sizer 07 HyProCure Sizer 06 HyProCure II Trial Sizer 09 HyProCure Sizer 08 osteo-WEDGE Drill Guide

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility