BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    PURPLE SURGICAL INTERNATIONAL LIMITED

    Reg #: 3008439467 · FEI: 3008439467 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    27
    Establishment Types
    3
    Classifications
    14

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    Registration Details

    Registration Name
    PURPLE SURGICAL INTERNATIONAL LIMITED
    Registration Number
    3008439467
    FEI Number
    3008439467
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2 Chestnut House, Farm Close, Shenley
    City
    Herts England
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K142868

    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
    Bag, Intestine KGY
    Tubing, Noninvasive GAZ
    Tubing, Pressure And Accessories BYX
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Dissector, Surgical, General & Plastic Surgery GDI
    Camera, Surgical And Accessories KQM
    Curette, Surgical, General Use FZS
    Laparoscope, Gynecologic (And Accessories) HET
    Laparoscope, General & Plastic Surgery GCJ
    Infusor, Pressure, For I.V. Bags KZD
    Cannula, Manipulator/Injector, Uterine LKF
    Container, Specimen, Non-Sterile NNI
    Needle, Aspiration And Injection, Disposable GAA
    Tubing/Tubing With Filter, Insufflation, Laparoscopic NKC

    Proprietary Names

    Endo Retrieval Pouches - Various names and models PS3400, PS3401 Tissue Retrieval Pouches - Various names and models PS6100 5mm Laparoscopic Electrodes Monopolar Cables Laparoscopic Blunt Tip Disector 5 x 41cm Single Use PS3885, PS3886 Various names and models Camera Sleeve - Various names and models PS3900 PS6204 Curette Flexible 4 mm PS6205 Curette Flexible, 5 mm PS6206 Curette Flexible 6 mm, PS6207 Curette Flexible 7 mm PS6208 Curette Flexible 8 mm, PS6210 Curette Flexible 10 mm, PS6212 Curette Flexible 12 mm PS6010 Curette, Rigid, Straight 10 mm, PS6011 Curette, Rigid, Straight 11 mm, PS6012 Curette, Rigid, Straight 12 mm PS6007 Curette, Rigid, Straight 7 mm, PS6008 Curette, Rigid, Straight 8 mm, PS6009 Curette, Rigid, Straight 9 mm PS6107 Curette, Rigid, Curved 7 mm, PS6108 Curette, Rigid, Curved 8 mm, PS6109 Curette, Rigid, Curved 9 mm PS6110 Curette, Rigid, Curved 10 mm, PS6111 Curette, Rigid, Curved 11 mm, PS6112 Curette, Rigid, Curved 12 mm Model Number: PS3852ULT & Laparascopic Accessories Purple Surgical International Ltd Disposable Trocar PS3871 Irrigation Pump PS3111 Uterine Manipulator - Various names and models Tissue Trap filter with adaptor Various names and Models Aspiration Needle (PS3895) Insufflation Filter Tubing Sets - Various names and models PS3600, PS3601, PS3602, PS3603, PS3604, PS3605

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Manufacture Medical Device