BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Irrisept Antimicrobial Wound Lavage, Wound Solution Kit

    Reg #: 3005706359 · FEI: 3005706359 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    IRRIMAX CORPORATION
    Registration Number
    3005706359
    FEI Number
    3005706359
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1665 Lakes Parkway, Suite 102
    City
    Lawrenceville
    State
    GA
    ZIP
    30043
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240552

    Owner / Operator

    Firm Name
    IRRIMAX CORPORATION
    Operator Number
    9086561
    Address
    1665 Lakes Parkway, Suite 102
    City
    Lawrenceville
    State
    GA
    Postal Code
    30043
    Country
    US
    Correspondent
    Richard W Holecek

    Products

    Device Name Product Code
    Dressing, Wound, Drug FRO

    Proprietary Names

    Irrisept Antimicrobial Wound Lavage, Wound Solution Kit Irrisept Antimicrobial Wound Lavage, Accessories Kit

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility