BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Rotaglide Lubricant

    Reg #: 1225687 · FEI: 3001451463 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Boston Scientific Corp., Marina Bay Cust. Fulfillment Center
    Registration Number
    1225687
    FEI Number
    3001451463
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    500 Commander Shea Boulevard
    City
    QUINCY
    State
    MA
    ZIP
    02171
    Country
    US

    Regulatory Submissions

    PMA Number
    P900056

    Owner / Operator

    Firm Name
    Boston Scientific Corporation
    Operator Number
    9912058
    Address
    300 Boston Scientific Way
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US

    Products

    Device Name Product Code
    Catheter, Coronary, Atherectomy MCX

    Proprietary Names

    Rotaglide Lubricant RotaLink Plus Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device Rotablator Dynaglide Foot Pedal wireClip Torquer ROTAPRO Rotational Atherectomy System Console Kit ROTAPRO Advancer Burr Advancing Device ROTAPRO Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device RotaWire and wireClip Torquer Extra Support ROTAWIRE Drive and wireClip Torquer Extra Support RotaWire and wireClip Torquer Floppy Rotablator Rotational Atherectomy System Console Kit RotaLink Advancer Catheter Advancing Device ROTAWIRE Drive and wireClip Torquer Floppy RotaLink Burr Exchangeable Burr Catheter

    Establishment Types

    Manufacture Medical Device