BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AQUACEL AG SURGICAL SP 9X35CM (1X10)NAI

    Reg #: 1058584 · FEI: 1000219637 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    1058584
    FEI Number
    1000219637
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10811 Withers Cove Park Drive
    City
    Charlotte
    State
    NC
    ZIP
    28278
    Country
    US

    Regulatory Submissions

    510(k) Number
    K152926

    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
    Dressing, Wound, Drug FRO

    Proprietary Names

    AQUACEL AG SURGICAL SP 9X35CM (1X10)NAI AQUACEL AG SURGICAL SP 9X15CM (1X10)NAI AQUACEL AG SURGICAL SP 9X10CM (1X10)NAI AQUACEL AG SURGICAL SP 9X30CM (1X10)NAI AQUACEL AG SURGICAL SP 9X25CM (1X10)NAI AQUACEL Advantage Surgical Cover Dressing (9x25cm) AQUACEL Advantage Surgical Cover Dressing (9x30cm) AQUACEL Advantage Surgical Cover Dressing (9x35cm) AQUACEL Advantage Surgical Cover Dressing SP (9x25cm) AQUACEL Advantage Surgical Cover Dressing SP (9x10cm) AQUACEL Advantage Surgical Cover Dressing (9x10cm) AQUACEL Advantage Surgical Cover Dressing SP (9x30cm) AQUACEL Advantage Surgical Cover Dressing (9x15cm) AQUACEL Advantage Surgical Cover Dressing SP (9x15cm) AQUACEL Advantage Surgical Cover Dressing SP (9x35cm)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)