BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DISPOSABLE WET-FIELD CABLE

    Reg #: 1319639 · FEI: 1000138054 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    31
    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
    K881001

    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
    Apparatus, Cautery, Radiofrequency, Battery-Powered HQQ

    Proprietary Names

    DISPOSABLE WET-FIELD CABLE HEMO DISP CVD ERASER ERASER,23 GA.,CVD.,90 DEG.,TAPERED/BLUNT ERASER, 23 GA. 135 DEG. FINE SHARP Wet-Field DISPOSABLE WET-FIELD CABLE, SHROUDED ERASER,25G,CVD,150 DEG. Wet-Field HEMO ERASER, 23GA BLUNT ERASER,20 GA.,135 DEG. CVD. ERASER,23G,STRAIGHT ERASER, 23 GA. 150 DEG. CVD. SHARP Wet-Field ERASER,25G,CVD,135 DEG. Wet-Field k881001 HEMO DISP ERASER 18GA ERASER,25G,STRAIGHT HEMO ERASER, 23GA TAPERED Eraser, 23GA Straight, Blunt ERASER,20 GA.,150 DEG. CURVED ERASER, 23 GA., 135 DEG CVD., BLUNT Wet-Field ERASER, 23 GA.,90 DEG CVD., BLUNT Wet-Field ACCU-TEMP CAUT LOOP TIP ACCU-TEMP 2" SHAFT LPTP VARI-STAT CAUTERY VASECTOR CAUTERY ACCU-TEMP CAUT FINE TIP VARI-TEMP CAUTERY SWITCH-A-TIP,2.5CM,LOOP I-STAT CAUTERY ACCU-TEMP CAUTERY 2"FINE TIP SWITCH-A-TIP 2.5CM FINE HEMO DISP ERASER 20GA ERASER, 23 GA., 150 DEG CVD., BLUNT Wet-Field hemo disp eraser 18ga

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)