BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    Advanced DSP Backflush Soft Tip, 20Ga

    Reg #: 3005941719 · FEI: 3002807111 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics Belgium Petit Rechain S.A.
    Registration Number
    3005941719
    FEI Number
    3002807111
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Zoning Industriel de Petit-Rechain, Avenue Andre Ernst 21
    City
    Verviers Liege
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K911808

    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
    Unit, Phacofragmentation HQC

    Proprietary Names

    Advanced DSP Backflush Soft Tip, 20Ga Advanced DSP Backflush Soft Tip, 25Ga STOP COCK, 3-WAY, WHT, IRR. Advanced DSP Backflush Blunt, 23Ga Advanced DSP Backflush Soft Tip, 23Ga STOPCOCK, 3-WAY, YELLOW, IRR Advanced DSP Backflush Blunt, 25Ga Advanced DSP Backflush Blunt, 20Ga DSP 20 Ga Fiberoptic End Grasping Forceps STOPCOCK, 90D HDL, 3-WAY, HD, IRR LAUREATE™ Anterior Vitrectomy Tip

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)