BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Catheter Introducer

    Reg #: 3011024991 · FEI: 3011024991 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Nypro Inc (Maple Grove)
    Registration Number
    3011024991
    FEI Number
    3011024991
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    11400 73rd Ave N Ste 100
    City
    Maple Grove
    State
    MN
    ZIP
    55369
    Country
    US

    Regulatory Submissions

    510(k) Number
    K152090

    Owner / Operator

    Firm Name
    Jabil Inc.
    Operator Number
    9074019
    Address
    10800 Roosevelt Blvd.
    City
    Saint Petersburg
    State
    FL
    Postal Code
    33716
    Country
    US

    Products

    Device Name Product Code
    Reprocessed Catheter Introducer PNE
    Introducer, Catheter DYB

    Proprietary Names

    Catheter Introducer Reprocessed catheter introducer

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)