BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    PS3111

    Reg #: 3008439467 · FEI: 3008439467 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PURPLE SURGICAL INTERNATIONAL LIMITED
    Registration Number
    3008439467
    FEI Number
    3008439467
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 Chestnut House, Farm Close, Shenley
    City
    Herts England
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K022503

    Owner / Operator

    Firm Name
    Purple Surgical International Limited
    Operator Number
    10033672
    Address
    2 Chestnut House, Farm Close, Shenley
    City
    Herts
    State
    England
    Postal Code
    WD7 9AD
    Country
    GB

    US Agent

    Business Name
    mdi Consultants, Inc.
    Contact Name
    Alan Schwartz
    Address
    55 Northern Blvd.
    City
    Great Neck
    State
    NY
    ZIP
    11021
    Country
    US
    Email
    [email protected]
    Phone
    516 4829001

    Products

    Device Name Product Code
    Cannula, Manipulator/Injector, Uterine LKF

    Proprietary Names

    PS3111 Uterine Manipulator - Various names and models

    Establishment Types

    Repack or Relabel Medical Device