BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PC COATED SI VENT TUBE1.14 (2)

    Reg #: 1649518 · FEI: 3001236277 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    1649518
    FEI Number
    3001236277
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3125 Wichita Court
    City
    Fort Worth
    State
    TX
    ZIP
    76140
    Country
    US

    Regulatory Submissions

    510(k) Number
    K062372

    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
    Lambda, Antigen, Antiserum, Control DEH
    Kappa, Antigen, Antiserum, Control DFH

    Proprietary Names

    PC COATED SI VENT TUBE1.14 (2) 50 DURO COLLAR BUTTON PC DOUBLE PC COATED SI VENT TUBE-BOJRAB PC COATED SI VENT TUBE1.27MM(2) PC COATED SI VENT TUBE-1.35MM PC COATED SI VENT TUBE-1.14MM PC COATED SI VENT TUBE1.14MM(2) PC Coated SILICONE VENT TUBE-ARMSTRONG PC VENT TUBE - TAPERVENT - 1.27mm ID PC COATED SI VENT TUBE1.35MM(2) PC COATED SI VENT TUBE1.27 (2) 50 DURO COLLAR BUTTON PC SINGLE PC COATED SI VENT TUBE-12MM PC COATED SI VENT TUBE12 (2) SIL TMPTUBE-DONALDSON-XTAB-1.14 ID PC COATED SI VENT TUBE-1.27MM PC COATED SI VENT TUBE 1.27MM(2) 1.14MM PC Ctd Silic Vnt Tub Pap w/tab PC COATED SI VENT TUBE BOJRAB(2)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)