BEUDAMED
    FDA Registration Active 🇺🇸 United States

    M-408-10

    Reg #: 1061124 · FEI: 1000512168 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    75
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    1061124
    FEI Number
    1000512168
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10821 Withers Cove Park Dr
    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
    Protector, Skin Pressure FMP

    Proprietary Names

    M-408-10 Protector, skin pressure 91101 SuperBump 8512/50 17590/20 2629 803-GP-10 907-GP-10 KNEEPAD/25 8541/50 8515/25 17408/20 17411/20 15516/24 17519/24 8544/100 SteriBump 7901W/25 17792/50 7908W/03 17410/50 8542/100 8527/50 7908W/25 17434/24 MEG012/20 8513/50 1745/25 8514/50 8525/50 1749/20 17412/20 17430/25 8533/100 7907W/03 17145/20 1746/20 8543/10 8555/20 PPPS01/10 8514/25 17413/20 PPPS08/10 17133/20 16120/24 7904W/10 8511/50 7903W/25 1741/50 8520/50 8511/20 14120/24 1742/25 17023/50 1742/10 17524/50 KNEEPLACER/10 FBP12/25 PPPS05/10 NSP001/10 7909W/03 8541/40 8523/50 1743/25 8522/50 7905W/20 17424/50 1744/25 8516/50 1747/20 508-E 803-GPE-10 Allevyn Life 907-GPE-10 CAST PADDING

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)