BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Zurpaz Steerable Sheath M004USMCA85200 (Medium Curl Asymmetric Curve)

    Reg #: 3004193842 · FEI: 3004193842 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Creganna Medical Ireland, Limited
    Registration Number
    3004193842
    FEI Number
    3004193842
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    PARKMORE WEST
    City
    BALLYBRIT Galway
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K131079

    Owner / Operator

    Firm Name
    Creganna Medical Ireland, Limited
    Operator Number
    9054708
    Address
    Parkmore West
    City
    Ballybrit
    State
    Galway
    Postal Code
    H91VN2T
    Country
    IE

    US Agent

    Business Name
    Creganna Medical
    Contact Name
    Tafzeelur Rahaman
    Address
    5905 Trenton Lane N, Plymouth
    City
    Minneapolis
    State
    MN
    ZIP
    55442
    Country
    US
    Email
    [email protected]
    Phone
    408 8564459

    Products

    Device Name Product Code
    Introducer, Catheter DYB

    Proprietary Names

    Zurpaz Steerable Sheath M004USMCA85200 (Medium Curl Asymmetric Curve) Zurpaz Steerable Sheath M004USMC85100 (Medium Curl, Symmetric Curve)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198