BEUDAMED
    FDA Registration Active 🇮🇳 India

    Dia 2.5mm X 200 mm Drill Bit (For Knotless Anchor)

    Reg #: 3010303097 · FEI: 3010303097 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    32
    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
    Bit, Drill HTW

    Proprietary Names

    Dia 2.5mm X 200 mm Drill Bit (For Knotless Anchor) Auxilock FlyKuter Dia 12mm, Type-I Dia 3.2mm X 200 mm Drill Bit (For Knotless Anchor) Dia 2.4mm X 300mm Drill Bit Auxilock FlyKuter Dia 8.5mm, Type-I Auxilock FlyKuter DIa 10.5mm, Type-I Auxilock FlyKuter Dia 11.5mm, Type-I Dia 1.5mm X 300mm Drill Bit, Stainless Steel 8 Point Drill Guide, Long Dia 2.5mm X 360mm Knotless Drill bit, Long Dia 1.2mm X 100mm Drill Bit Auxilock FlyKuter Dia 7.5mm, Type-I Dia 1.8mm X 325 mm Drill Bit Dia 1.5mm X 300mm Drill Bit, Nitinol DIa 2.8mm X 300mm Drill Bit Dia 1.8mm X 200mm Drill Bit Auxilock FlyKuter Dia 10mm, Type-I Auxilock FlyKuter Dia 6.5mm, Type-I Auxilock FlyKuter Dia 11mm, Type-I Auxilock FlyKuter Dia 9mm, Type-I Dia 2.4mm X 200mm Drill Bit Cannulated Drill Bit with Quick Coupling End, Dia 3.5mm X Length 175mm Dia 2.8mm X 200mm Drill Bit Dia 1.8mm X 300mm Drill Bit Auxilock FlyKuter Dia 7mm, Type-I Auxilock FlyKuter Dia 9.5mm, Type-I Dia 3.2mm X 200mm Drill Bit Dia 2.8mm X 100mm Drill Bit Dia 1.2mm X 110mm Drill Bit Auxilock FlyKuter Dia 8mm, Type-I Dia 1.8mm X 100mm Drill Bit Pin, Drill Tip, Dia 2.4mm x 355mm

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device