BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Wet-Field

    Reg #: 1319639 · FEI: 1000138054 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    21
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    1319639
    FEI Number
    1000138054
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    84 Park Rd
    City
    Queensbury
    State
    NY
    ZIP
    12804
    Country
    US

    Regulatory Submissions

    510(k) Number
    K911160

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    Wet-Field WET-FIELD ERASER 25 GA FINE TIP 135 WET-FIELD ERASER 20 GA BLUNT TIP 150 WET-FIELD OSHER THERMODOT MARKER 25 GA FINE TIP WET-FIELD ERASER 20-23 GA TAPERED BLUNT TIP STRAIGHT WET-FIELD ERASER 18 GA BLUNT TIP 45 WET-FIELD ERASER 23 GA BLUNT TIP 150 WET-FIELD ERASER 20-23 GA TAPERED FINE TIP STRAIGHT WET-FIELD ERASER 23 GA BLUNT TIP STRAIGHT WET-FIELD ERASER 20 GA BLUNT TIP STRAIGHT WET-FIELD ERASER 23 GA FINE TIP 135 WET-FIELD ERASER 23GA BLUNT TIP 90 WET-FIELD ERASER 23 GA FINE TIP 150 WET-FIELD ERASER 25 GA FINE TIP 150 WET-FIELD SINGLE USE BIOPOLAR CABLE SHROUNDED PIN WET-FIELD ERASER 23 GA BLUNT TIP 135 WET-FIELD ERASER 25 GA FINE TIP STRAIGHT WET-FIELD ERASER 23 GA FINE TIP STRAIGHT WET-FIELD ERASER 18 GA BEVEL TIP WET-FIELD ERASER 23 GA BLUNT TIP 90 WET-FIELD SINGLE USE BIOPOLAR CABLE

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)