BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GaltStick

    Reg #: 1649395 · FEI: 3000718472 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    GALT MEDICAL CORP.
    Registration Number
    1649395
    FEI Number
    3000718472
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2220 Merritt Dr
    City
    GARLAND
    State
    TX
    ZIP
    75041
    Country
    US

    Regulatory Submissions

    510(k) Number
    K071330

    Owner / Operator

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

    Products

    Device Name Product Code
    Dilator, Vessel, For Percutaneous Catheterization DRE

    Proprietary Names

    GaltStick

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device