BEUDAMED
    FDA Registration Active 🇺🇸 United States

    (MS) CG50080 -HORIZON PROCESSED WATER 30 CC LTX STER WTR SYR

    Reg #: 2022435 · FEI: 2022435 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    2022435
    FEI Number
    2022435
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1401 Morgan Cir
    City
    Tustin
    State
    CA
    ZIP
    92780
    Country
    US

    Regulatory Submissions

    510(k) Number
    K952414

    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
    Accessories, Catheter, G-U KNY

    Proprietary Names

    (MS) CG50080 -HORIZON PROCESSED WATER 30 CC LTX STER WTR SYR (MS) 10 CC STERILE WATER FILLED LATEX FREE 10CC STERILE WATER FILLED LATX (MS) 5CC STERILE WATER FILLED LATX 10CC SYR, 5CC STERILE WATER FI (MS) 310CC STERILE WATER FILLED LAT (MS) 20 CC STERILE WATER FILLED SYRINGE, TELEFLEX (MS) PK 119 - 10CC STERILE WATER FILLED LATEX FREE SYRINGE, (MS) 10 CC STERILE WATER FILLED LATX 30 cc STERILE WATER FILLED LATEX FREE SYRINGE (MS) HORIZON PROCESS WATER/10CC STERILE WATER FILLED SYRINGE (MS) CG3076 - 10 CC STERILE WATER FILLED LATX FREE SYR, (MS) 30 CC STERILE WATER FILLED LATEX FREE SYRINGE (MS) CG3151 - 3.5 CC STERILE WATER FILLED SY (MS) 5 CC STERILE WATER FILLED LATX FREE SYR,

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)