BEUDAMED
    FDA Registration Active 🇺🇸 United States

    steri-shield face guard

    Reg #: 3005142514 · FEI: 3005142514 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SYNTECH INTERNATIONAL
    Registration Number
    3005142514
    FEI Number
    3005142514
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    17171 DAIMLER AVE.
    City
    IRVINE
    State
    CA
    ZIP
    92614
    Country
    US

    Regulatory Submissions

    510(k) Number
    K881913

    Owner / Operator

    Firm Name
    BIO-MEDICAL DEVICES
    Operator Number
    2083467
    Address
    17171 DAIMLER AVE., --
    City
    Irvine
    State
    CA
    Postal Code
    92614
    Country
    US
    Correspondent
    NICK - HERBERT

    Products

    Device Name Product Code
    Mask, Surgical FXX

    Proprietary Names

    steri-shield face guard low profile wrap around lens sterishield head gear wrap around lens sterile short lens sterile low profile short lens sterishield wrap around lens sterishield

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device