BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VAC X-LARGE GRANUFOAM DRESSING (EASTERN EUROPE), 5 PACK

    Reg #: 2022435 · FEI: 2022435 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    33
    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
    K992448

    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
    Negative Pressure Wound Therapy Powered Suction Pump OMP

    Proprietary Names

    VAC X-LARGE GRANUFOAM DRESSING (EASTERN EUROPE), 5 PACK KCI STAND ALONE TRAC PAD ASSY 10 PACK, EE KCI ABDOMINAL DRESSING ASSEMBLY W/SENSATRAC, 5 PACK VAC INSTILL IRRIGATION TUBING - 5 PACK KCI SENSA TRAC GRANUFOAM SMALL SPIRAL DRESSING, 5PK KCI SENSA TRAC GRANUFOAM MEDIUM SPIRAL DRESSING, 5PK VAC GRANUFOAM SILVER LARGE DRESSING - 10 PACK SENSATRAC, THIN VAC GRANUFOAM DRESSING 5 PACK KCI VERSA (SOFT WHITE) FOAM TRAC DRESSING SUB-ASSEMBLY VAC GRANUFOAM SILVER SMALL DRESSING - 10 PACK KCI DIABETIC FOOT ULCER [DFU] - 5 PACK KCI TRAC DRESSING, MEDIUM FOAM, 10 PACK, EE VAC DRAPE, 10-PACK VAC GRANUFOAM LARGE BRIGDE DRESSING USING THE 10 PACK KCI DIABETIC FOOT ULCER [DFU] - 10 PACK OPEN ABDOMINAL DRESSING, 5-PACK KCI TRAC DRESSING, SMALL FOAM, 5 PACK, EE KCI SOFT WHITE FOAM TRAC DRESSING SUB-ASSEMBLY KCI TRAC DRESSING, SMALL FOAM, 10 PACK, EE KCI TRAC DRESSING, LARGE FOAM, 5 PACK, EE VAC INSTILL IRRIGATION - 5 PACK VAC DRAPE, 10-PACK, EE HEEL DRESSING ASSEMBLY W/SENSATRAC, 5 PACK KCI TRAC DRESSING, SMALL FOAM, 10 PACK SENSATRAC, ROUND GRANUFOAM DRESSING 10 PACK KCI SENSA TRAC GRANUFOAM SMALL SPIRAL DRESSING, 10PK KCI SENSA TRAC GRANUFOAM MEDIUM SPIRAL DRESSING, 10PK VAC GRANUFOAM SILVER MEDIUM DRESSING - 10 PACK KCI ABDOMINAL DRESSING ASSEMBLY W/NON-ADHERENT LAYER, 5 PACK KCI TRAC DRESSING, LARGE FOAM, 10 PACK, EE VAC INSTILL IRRIGATION PAD - 5 PACK KCI TRAC DRESSING, MEDIUM FOAM, 5 PACK, EE HEEL DRESSING ASSEMBLY, 5 PACK

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)