BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SenSura Click

    Reg #: 3006371704 · FEI: 3006371704 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    28
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    RR DONNELLEY-SUPPLY CHAIN SOLUTIONS
    Registration Number
    3006371704
    FEI Number
    3006371704
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1600 DISK DR.
    City
    Plover
    State
    WI
    ZIP
    54467
    Country
    US

    Regulatory Submissions

    510(k) Number
    K840269

    Owner / Operator

    Firm Name
    RRDonnelley
    Operator Number
    9077726
    Address
    1600 Disk Drive
    City
    Plover
    State
    WI
    Postal Code
    54467
    Country
    US
    Correspondent
    Lee Rush

    Products

    Device Name Product Code
    Collector, Ostomy EXB

    Proprietary Names

    SenSura Click 12273 MIO430 FLEX POUCH,50MM SenSura Mio Flex 12283 MIO430 FLEX POUCH,70MM 11512 FLEX POUCH RED 10561 MIO FLEX SKIN BARRIER 120427 MOLDABLE RINGS,4.2MM 14305 ASSURA AC SKIN BARRIER XTND WEAR SenSura Flex 10105 SKIN BARRIER FLANGE RED SenSura X-pro 10106 SKIN BARRIER FLANGE YELLOW 11517 FLEX POUCH YELLOW 10108 SKIN BARRIER 14554 ASSURA AC POUCH MULTI TRP SenSura Mio Pro 11483 MIO430 CLICK POUCH SenSura Mio 10522 MIO CLICK SKIN BARRIER 12272 MIO FLEX POUCH 11482-MIO 2PC CLICK POUCH 11856 POUCH SenSura Mio Original 10571 MIO FLEX SKIN BARRIER 10035 Skin Barrier SenSura Mio Click 120700 Barrier Strips Brava Mouldable Rings

    Establishment Types

    Repack or Relabel Medical Device