BEUDAMED
    FDA Registration Active 🇮🇳 India

    8 Point Slotted Drill Guide, Length 190mm

    Reg #: 3010303097 · FEI: 3010303097 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    28
    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
    Guide, Surgical, Instrument FZX

    Proprietary Names

    8 Point Slotted Drill Guide, Length 190mm Transtibial Femoral Offset Guide, 5mm Single Lumen Cannula for Meniscal Repair, 30 Degree Curve Femoral ACL Guide, Left PCL Tibial Guide with O Tip Drill Sleeve For FlyKuter Transportal Femoral Offset Guide 5mm Slotted Cannula Single Lumen Cannula for Meniscal Repair, Straight Guide Pin Sleeve Femoral ACL Guide, Right 8 Point Drill Guide, Length 100mm Single Lumen Cannula for Meniscal Repair, 40 Degree Curve 8 Point Slotted Drill Guide, Length 50mm Drill Guide Handle Transtibial Femoral Offset Guide, 7mm Single Lumen Cannula for Meniscal Repair, 10 Degree Curve Tibial ACL Marking Hook 8 Point Drill Guide Single Lumen Cannula for Meniscal Repair, 20 Degree Curve V-Mouth Drill Guide PCL Femoral Guide Transtibial Femoral Offset Guide, 6mm V-Mouth Drill Guide - Curve Bender for Cannula PCL Tibial Guide with C Tip Transportal Femoral Offset Guide, 6mm Transportal Femoral Offset Guide, 7mm

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device