BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SAFESOURCE DIRECT

    Reg #: 3021486363 · FEI: 3021486363 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    SAFESOURCE DIRECT
    Registration Number
    3021486363
    FEI Number
    3021486363
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    200 St. Nazaire Road
    City
    Broussard
    State
    LA
    ZIP
    70518
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221134

    Owner / Operator

    Firm Name
    SafeSource Direct
    Operator Number
    10084021
    Address
    200 St. Nazaire Road
    City
    Broussard
    State
    LA
    Postal Code
    70518
    Country
    US

    Products

    Device Name Product Code
    Cover, Shoe, Operating-Room FXP
    Mask, Surgical FXX
    Non-Surgical Gown OEA
    Cap, Surgical FYF

    Proprietary Names

    SafeSource Direct Universal Shoe Cover SafeSource Direct XL Extra Traction Shoe Cover SafeSource Direct Universal Extra Traction Shoe Cover SafeSource Direct XL Shoe Cover SafeSource DIrect Procedure Mask with Ear Loops -Level 3 SafeSource DIrect Surgical Mask with Ties - Level 3 SafeSource DIrect Surgical Mask with Ties - Level 1 SafeSource DIrect Procedure Mask with Ear Loops - Level 1 Level 2 Isolation Gown Level 1 Isolation Gown SafeSource DIrect Plant Based Procedural Masks with Earloops - Level 3 PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops PADM PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops SafeSource Direct Disposable Bouffant SafeSource Direct Lay Flat Bouffant

    Establishment Types

    Manufacture Medical Device