BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Gemcision Trapazoid Blade

    Reg #: 3007589150 · FEI: 3007589150 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    16
    Establishment Types
    5
    Classifications
    1

    Registration Details

    Registration Name
    KATALYST SURGICAL, LLC
    Registration Number
    3007589150
    FEI Number
    3007589150
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    754 Goddard ave
    City
    Chesterfield
    State
    MO
    ZIP
    63005
    Country
    US

    Owner / Operator

    Firm Name
    Katalyst Surgical, LLC
    Operator Number
    10029103
    Address
    754 Goddard Avenue
    City
    Chesterfield
    State
    MO
    Postal Code
    63005
    Country
    US
    Correspondent
    Meryl Koch

    Products

    Device Name Product Code
    Knife, Ophthalmic HNN

    Proprietary Names

    Gemcision Trapazoid Blade Gemcision Paracentesis-Super Sharp Gemcision LRI Blade Gemcision Paracentesis-Super Sharp, Sharp Sides Gemcision Keratome Lancet-Super Sharp, Sharp Sides LRI Diamond Knife Diamond Dual Bevel Gemcision Keratome Lancet Keratome Diamond Knife Gemcision Crescent Blade-Sharp Sides Diamond Clear Cornea Blade Step Diamond Knife Diamond Paracentesis Knife Gemcision Keratome Lancet-Super Sharp Dhaliwal Scleral Buckle Hockey Stick Blade Dhaliwal Scleral Buckle Crescent Blade

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Remanufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device