BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Compact Wound Seal

    Reg #: 1058584 · FEI: 1000219637 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    18
    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

    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, Hydrogel Without Drug And/Or Biologic NAE

    Proprietary Names

    Compact Wound Seal Wound Seal Duo DualSeal Glycocell 10cm x 10cm WCP-04-10-210 Glycocell VenFix i.v. WCP-04-03-314 Glycocell FixoFORM WCP-05-01-202 Glycocell Soft MiniFix i.v. WCP-06-01-302S Glycocell Soft 5x7cm WCP-04-05-307S Glycocell Soft MinFix WCP-06-01-301S Glycocell Soft SondoFix WCP-02-01-314S Glycocell Soft VenFix i.v. WCP-04-03-314S Glycocell SpinFIX WCP-01-02-302S Glycocell Soft SondoFix WCP-02-01-314 Glycocell LifeLINE. WCP-01-01312S Glycocell Soft 5x7cm WCP-04-05-307 Extreme Wound Seal H&H Wound Seal Kit Hydrogel with or without biologic

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)