BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Cotton Cannulatome II PC Protector

    Reg #: 1000393132 · FEI: 1000393132 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    COOK INCORPORATED
    Registration Number
    1000393132
    FEI Number
    1000393132
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6300 N. MATTHEWS DR.
    City
    ELLETTSVILLE
    State
    IN
    ZIP
    47429
    Country
    US

    Regulatory Submissions

    510(k) Number
    K172665

    Owner / Operator

    Firm Name
    COOK, INC.
    Operator Number
    1820334
    Address
    750 DANIELS WAY
    City
    Bloomington
    State
    IN
    Postal Code
    47404
    Country
    US

    Products

    Device Name Product Code
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS

    Proprietary Names

    Cotton Cannulatome II PC Protector Howell D.A.S.H. Direct Acess System Cannulatome II PC Double Lumen Sphincterotome UTS PRECURVED ULTRA TAPER SPHINCTEROTOME COTTON CANNULATOME D.A.S.H. Pre-Loaded with Acrobat 2 Wire Guide D.A.S.H. PRE-LOADED WITH ACROBAT 2 WIRE GUIDE DOUBLE LUMEN WIRE GUIDED BILLROTH II SPHINCTEROTOME Cotton Cannulatome II PC Double Lumen Sphincterotome D.A.S.H. Preloaded with Acrobat Wire Guide Howell D.A.S.H. Sphincterotome Cannulatome II PC Lumen Sphincterotome D.A.S.H. Dome Tip Double Lumen Sphincterotome Tri-Tome PC Triple Lumen Sphincterotomes Tri-Tome PC Protector Universal Active Cord

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)