BEUDAMED
    FDA Registration Active 🇮🇳 India

    CoDicil Reamer Sleeve

    Reg #: 3010303097 · FEI: 3010303097 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    87
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Auxein medical Private limited
    Registration Number
    3010303097
    FEI Number
    3010303097
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Plot No.168,169,170 Phase-IV, Sector 57, Kundli Industrial area,, HSIIDC Sonipat- 131028, Haryana, INDIA
    City
    Sonipat Haryana
    Country
    IN

    Owner / Operator

    Firm Name
    Auxein Medical Pvt Ltd
    Operator Number
    10046810
    Address
    Plot No.168,169,170 Phase-IV, Sector 57, Kundli Industrial area, HSIIDC Sonepat- 131028, Haryana, INDIA, HSIIDC Sonipat- 131028, Haryana, INDIA
    City
    Sonipat
    State
    Haryana
    Postal Code
    131028
    Country
    IN

    US Agent

    Business Name
    510K FDA Inc.
    Contact Name
    Lee Strong
    Address
    156 E Granada Blvd
    City
    Ormond Beach
    State
    FL
    ZIP
    32176
    Country
    US
    Email
    [email protected]
    Phone
    386 8466037

    Products

    Device Name Product Code
    Reamer HTO

    Proprietary Names

    CoDicil Reamer Sleeve Container for Ga-mma Nail Instrument Set Tap for Cephllic Screw (Lag Suew) Tray for Ga-mma Nail.butruments Driver for Nail Holding Screw Drill Bit 4mm :s: 350mm, Jacob Chuck Internal Sleeve for Guide Wire 3mm Inverted Gauge for Cephlllc Screw (Lag Screw) 3mm Guide Wire, Length 400mm Guide Sleeve for Distal Locking Screw Guide Sleeve for Cephalic Screw (Lag Screw) Spanner for Driver Screw Driver for End Cap for Cephllic Screw (Lag Screw) Trocar for Cephllic Screw (Lag Screw) Trocar for Distil Locking Screw Step Drill for Cephllic Screw (Lag Screw) lnJertor for Cephalic Screw (Lag Screw) One Step CoDicil Reamer 17mm Depth Gauge for Distal Locking Suew T Handle with SS Chuck & Key Sliding Hammer with E:rtractor Rod Socket Wrench, Univenal Screw Driver for Set Screw Targeting Device Nail Holding Screw Drill Sleeve for 4mm Drill Bit Flexible Cannulated Reamer Dia 5.5 mm For Knee ACL System Femoral Cannulated Reamer, Dia 9.5 mm Dia 3.2mm X 100mm Cannulated Reamer Dia 8mm Trocar Tip Headed Reamer Flexible Cannulated Reamer Dia 7.5 mm For Knee ACL System Tibial Cannulated Reamer, Dia 11 mm Dia 4.5mm Cannulated Headed Reamer Femoral Cannulated Reamer, Dia 11.5 mm Dia 6mm Trocar Tip Headed Reamer Flexible Cannulated Reamer Dia 8.5 mm For Knee ACL System Femoral Cannulated Reamer, Dia 8 mm Femoral Cannulated Reamer, Dia 10 mm Dia 9mm Trocar Tip Headed Reamer Flexible Cannulated Reamer Dia 8 mm For Knee ACL System Femoral Cannulated Reamer, Dia 7.5 mm Femoral Cannulated Reamer, Dia 6.5 mm Flexible Cannulated Reamer Dia 6 mm For Knee ACL System Tibial Cannulated Reamer, Dia 7mm Femoral Cannulated Reamer, Dia 11 mm Flexible Cannulated Reamer Dia 11.5 mm For Knee ACL System Femoral Cannulated Reamer, Dia 12 mm Tibial Cannulated Reamer, Dia 8.5 mm Tibial Cannulated Reamer, Dia 11.5 mm Tibial Cannulated Reamer, Dia 7.5mm Flexible Cannulated Reamer Dia 10.5 mm For Knee ACL System Flexible Cannulated Reamer Dia 11 mm For Knee ACL System Dia 3.5mm X 100mm Cannulated Reamer Flexible Cannulated Reamer Dia 10 mm For Knee ACL System Tibial Cannulated Reamer, Dia 6.5mm Flexible Cannulated Reamer Dia 6.5 mm For Knee ACL System Flexible Cannulated Reamer Dia 12 mm For Knee ACL System Tibial Cannulated Reamer, Dia 6mm Tibial Cannulated Reamer, Dia 12 mm Femoral Cannulated Reamer, Dia 8.5 mm Tibial Cannulated Reamer, Dia 9 mm Dia 4.5mm X 100mm Cannulated Reamer Flexible Cannulated Reamer Dia 7 mm For Knee ACL System Femoral Cannulated Reamer, Dia 10.5 mm Dia 6mm X 100mm Cannulated Reamer Dia 6mm Tocar Tip Headed Reamer Dia 6.5mm X 100mm Cannulated Reamer Tibial Cannulated Reamer, Dia 10 mm Dia 7mm Tocar Tip Headed Reamer Dia 3mm X 100mm Cannulated Reamer Flexible Cannulated Reamer Dia 4.7mm For Knee ACL System Dia 8mm Tocar Tip Headed Reamer Dia 9mm Tocar Tip Headed Reamer Dia 4mm X 100mm Cannulated Reamer Femoral Cannulated Reamer, Dia 7 mm Tibial Cannulated Reamer, Dia 10.5 mm Dia 7mm Trocar Tip Headed Reamer Tibial Cannulated Reamer, Dia 8 mm Dia 5.5mm X 100mm Cannulated Reamer Femoral Cannulated Reamer, Dia 6mm Flexible Cannulated Reamer Dia 9.5 mm For Knee ACL System Femoral Cannulated Reamer, Dia 9 mm Flexible Cannulated Reamer Dia 5 mm For Knee ACL System Cannulated Headed Reamer, Dia 4.7mm Tibial Cannulated Reamer, Dia 9.5mm Flexible Cannulated Reamer Dia 9 mm For Knee ACL System Dia 5mm X 100mm Cannulated Reamer

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device