BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Gilero, Inc

    Reg #: 3016733629 · FEI: 3016733629 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    13

    Registration Details

    Registration Name
    Gilero, Inc
    Registration Number
    3016733629
    FEI Number
    3016733629
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    158 Credle Street
    City
    Pittsboro
    State
    NC
    ZIP
    27312
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201936

    Owner / Operator

    Firm Name
    Gilero, Inc
    Operator Number
    10053703
    Address
    4319 S. Alston Ave., Suite 100
    City
    Durham
    State
    NC
    Postal Code
    27713
    Country
    US

    Products

    Device Name Product Code
    Syringe, Piston FMF
    Trap, Sterile Specimen BYZ
    Intravenous Catheter Force-Activated Separation Device. QOI
    Tube, Aspirating, Flexible, Connecting BYY
    Accessory, Surgical Apparel LYU
    Vapocoolant Device MLY
    Probe, Rectal, Non-Powered EXX
    Container, I.V. KPE
    Kit, Surgical Instrument, Disposable KDD
    Wire, Guide, Catheter, Exempt PTL
    Applicator, Absorbent Tipped, Sterile KXG
    Clamp, Vascular DXC
    Ventilator, Non-Continuous (Respirator) BZD

    Proprietary Names

    Specimen Basket Bone Basket Face Shield Speed Torque

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198