BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STERIZIGN PRECISION TECHNOLOGIES

    Reg #: 3014409963 · FEI: 3014409963 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    3

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    Registration Details

    Registration Name
    STERIZIGN PRECISION TECHNOLOGIES
    Registration Number
    3014409963
    FEI Number
    3014409963
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Tech Place 74 Orion Street
    City
    Brunswick
    State
    ME
    ZIP
    04011
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171520

    Owner / Operator

    Firm Name
    SteriZign Precision Technologies
    Operator Number
    10057269
    Address
    Tech Place 74 Orion Street
    City
    Brunswick
    State
    ME
    Postal Code
    04011
    Country
    US
    Correspondent
    Sonia Lutarewych

    Products

    Device Name Product Code
    Tray, Surgical, Instrument FSM
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Tray, Surgical, Needle FSH

    Proprietary Names

    MIZ2022-1 EVAN- Evans Rotatable Instrument tray MIZ2025-2 Adenoma Tray miz2022-4 EVAN Evans Rotatable Instrument Tray MIZ2025-1 Single Shaft Bipolar Tray SteriZign Signatur Device Cassette and Trays Sterilization Tray, Isto Biologics Standardyz

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device