BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Hem-Avert Perianal Stabilizer

    Reg #: 3005550381 · FEI: 3005550381 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STETRIX INC.
    Registration Number
    3005550381
    FEI Number
    3005550381
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6935 Appling Farms Pkwy Ste 103
    City
    Memphis
    State
    TN
    ZIP
    38133
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN160005

    Owner / Operator

    Firm Name
    Stetrix Inc.
    Operator Number
    9078700
    Address
    7531 Bartlett Corporate Cv E, Suite 103
    City
    Bartlett
    State
    TN
    Postal Code
    38133
    Country
    US
    Correspondent
    David D Blurton

    Products

    Device Name Product Code
    Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery PNU

    Proprietary Names

    Hem-Avert Perianal Stabilizer Labor Guard Perianal Stabilizer

    Establishment Types

    Manufacture Medical Device