BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Gelfoam-JMI Sponge Kit

    Reg #: 1000150646 · FEI: 3004393730 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Wyeth Pharmaceuticals LLC
    Registration Number
    1000150646
    FEI Number
    3004393730
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    500 Arcola Road
    City
    Collegeville
    State
    PA
    ZIP
    19426
    Country
    US

    Regulatory Submissions

    PMA Number
    N18286

    Owner / Operator

    Firm Name
    PFIZER INC.
    Operator Number
    9924008
    Address
    275 N Field Drive
    City
    Lake Forest
    State
    IL
    Postal Code
    60045
    Country
    US
    Correspondent
    Kathleen M Lins

    Products

    Device Name Product Code
    Agent, Absorbable Hemostatic, Collagen Based LMF

    Proprietary Names

    Gelfoam-JMI Sponge Kit Gelfilm Sterile Film; Gelfilm Sterile Ophthalmic Film Gelfoam Sterile Sponge, Gelfoam Dental Sponge, Gelfoam Sterile Compressed Sponge, Gelfoam Sterile Powder Gelfoam-JMI Powder Kit GEL-FLOW NT Gel-Flow Kit 6mL

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198