BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PIG1260K Single use, sterile procedural tray/kit Safe-T-Centesis Catheter Drainage Device, 6 Fr

    Reg #: 3004111573 · FEI: 3004111573 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    38
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    3004111573
    FEI Number
    3004111573
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1302 Avenue T
    City
    Grand Prairie
    State
    TX
    ZIP
    75050
    Country
    US

    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
    Needle, Catheter GCB

    Proprietary Names

    PIG1260K Single use, sterile procedural tray/kit Safe-T-Centesis Catheter Drainage Device, 6 Fr PIG1280TSP Single use, sterile procedural tray/kit Safe-T-Centesis PLUS 8 Fr Catheter Drainage Tray PIG1260T Single use, sterile procedural tray/kit Safe-T-Centesis Catheter Drainage Tray, 6 Fr TPT1000SP Single use, sterile procedural tray/kit Safe-T PLUS Thoracentesis/Paracentesis Tray w/8 Fr Catheter and UDS TPT1000 Single use, sterile procedural tray/kit Thoracentesis/Paracentesis Tray Safe-T PLUS Thoracentesis/Paracentesis Tray w/8 Fr Catheter and UDS Thoracentesis/Paracentesis Tray Safe-T-Centesis PLUS 8 Fr Catheter Drainage Tray Thoracentesis Tray with Catheter Skater Introducer Sets Thoracentesis Tray with 16g, 3" Aspirating needle Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray, PIG1280T M-Drain™ Centesis TPT1000 OTP5000K TPK1005 TPT1005SP PIG1280TSP TPT1005 4340A TPK1001 TPT1005SDF TPT1000CDF Access Needle 4341B PIG1260T TPT1005CDF PIG1260TSP PIG1260TCDF OTP5000 TPT1000SP PIG1280K Single use, sterile procedural tray/kit Safe-T-Centesis Catheter Drainage Device, 8 Fr PIG1280T Single use, sterile procedural tray/kit Safe-T-Centesis Catheter Drainage Tray, 8 Fr TPK1001 Single use, sterile procedural tray/kit Thoracentesis/Paracentesis Tray "Introducer Needle with Trocar Stylet MAK-NV PIG1260TSP Single use, sterile procedural tray/kit Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray, TPT1000SDF Single use, sterile procedural tray/kit Safe-T PLUS Thoracentesis/Paracentesis Tray w/8 Fr Catheter and UDS,

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)