BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    Theragenics Costa Rica Limitada

    Reg #: 3011623145 · FEI: 3011623145 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    3

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    Registration Details

    Registration Name
    Theragenics Costa Rica Limitada
    Registration Number
    3011623145
    FEI Number
    3011623145
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Zona Franca El Coyol, Building B 13.3
    City
    El Coyol Alajuela
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K123430

    Owner / Operator

    Firm Name
    Theragenics Corporation
    Operator Number
    1037598
    Address
    5203 BRISTOL INDUSTRIAL WAY, --
    City
    Buford
    State
    GA
    Postal Code
    30518
    Country
    US

    US Agent

    Business Name
    Galt Medical Corp
    Contact Name
    David Derrick
    Address
    2220 Merritt Dr
    City
    Garland
    State
    TX
    ZIP
    75041
    Country
    US
    Email
    [email protected]
    Phone
    214 7781306

    Products

    Device Name Product Code
    Introducer, Catheter DYB
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Percutaneous Sheath Introducer Kit OFL

    Proprietary Names

    MicroSlide Tearaway Introducer Coaxial Medcomp® BREEZE® AND BREEZE® XS INTRODUCER KIT Galt Medical Corp. Introducer Kits Micro-Access Tearaway Elite HV GaltStick Dilator

    Establishment Types

    Manufacture Medical Device