BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Ethicon PDS II SUTURES

    Reg #: 3011357022 · FEI: 3011357022 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    PREMIER OSTOMY CENTRE INC.
    Registration Number
    3011357022
    FEI Number
    3011357022
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6607 Cote des Neiges
    City
    Montreal Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K183183

    Owner / Operator

    Firm Name
    Premier Ostomy Centre Inc.
    Operator Number
    10058163
    Address
    6607 Cote des Neiges
    City
    Montreal
    State
    Quebec
    Postal Code
    H3S 2B3
    Country
    CA
    Correspondent
    Joel Goldenberg

    Products

    Device Name Product Code
    Suture, Surgical, Absorbable, Polydioxanone NEW
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM

    Proprietary Names

    Ethicon PDS II SUTURES

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device