BEUDAMED
    FDA Registration Active 🇺🇸 United States

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

    Reg #: 1721676 · FEI: 1721676 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    38
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    1721676
    FEI Number
    1721676
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5725 Harold Gatty Dr
    City
    Salt Lake City
    State
    UT
    ZIP
    84116
    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)