BEUDAMED
    FDA Registration Active 🇫🇷 France

    Anti-Block Catheter 9cm Scopea

    Reg #: 3007156625 · FEI: 3008133910 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    31
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics SAS
    Registration Number
    3007156625
    FEI Number
    3008133910
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8 Rue Parmentier
    City
    Rantigny Oise
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K853362

    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
    Shunt, Central Nervous System And Components JXG

    Proprietary Names

    Anti-Block Catheter 9cm Scopea Slotted Catheter Reservoir 4cm Anti-Block Catheter 12cm Scope Anti-Block Catheter 8cm Scopea Slotted Catheter Reservoir 9cm Anti-Block Catheter 10cm Scope Neonatal Catheter Reservoir 4c Phoenix Slotted Right Angle ca Slotted Catheter Reservoir 8cm Slotted Catheter Reservoir 10c Phoenix Slotted Cathter Reserv Slotted Catheter Reservoir 12c Anti-Block Catheter 7cm Scopea Anti-Block Catheter 6cm Scopea Slotted Catheter Reservoir 6cm Anti-Block Catheter 11cm Scope Neonatal Reservoir - 7cm Slotted Catheter Reservoir 7cm Slotted Right Angle Catheter 9 Neonatal Reservoir - 6cm Neonatal catheter reservoir 3c Phoenix Slotted Catheter Slotted Catheter Reservoir 11c Slotted Right Angle Catheter 8 Anti-Block Catheter 4cm Scopea Slotted right angle catheter 7 Slotted Right Angle Catheter 6 Neonatal Reservoir - 5cm Endoscopic right angle, Anti-Blok ventricular catheter with reservoir, 3 cm Slotted Right Angle Catheter 5 Anti-Block Catheter 5cm Scopea

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)