BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GentleTouch Loop Ostomy Systems - Post Operative Kits

    Reg #: 3011987967 · FEI: 3011987967 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ConvaTec, Inc.
    Registration Number
    3011987967
    FEI Number
    3011987967
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    7815 National Service Road, Suite 600
    City
    Greensboro
    State
    NC
    ZIP
    27409
    Country
    US

    Regulatory Submissions

    510(k) Number
    K811240

    Owner / Operator

    Firm Name
    ConvaTec
    Operator Number
    2241599
    Address
    7815 National Service Road, Suite 600
    City
    Greensboro
    State
    NC
    Postal Code
    27409
    Country
    US
    Correspondent
    Courtney Smith

    Products

    Device Name Product Code
    Collector, Ostomy EXB
    Rod, Colostomy EZP

    Proprietary Names

    GentleTouch Loop Ostomy Systems - Post Operative Kits SUR-FIT Loop Ostomy Rod ESTEEM SYNERGY Professional Kit NATURA Stomahesive Skin Barrier Drainable Pouch Post Operative Kit with Loop Ostomy Rod Loop Ostomy Rod ConvaTec Loop Ostomy Rod ESTEEM synergy Professional Kit - Loop Ostomy System Loop Ostomy Kits NATURA Stomahesive Post Operative Surgical Ostomy System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198