BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    DUP48501N Sterile Saline 4 FL oz

    Reg #: 9680091 · FEI: 3002806830 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DERMA SCIENCES CANADA, INC (dba DERMA SCIENCES, INC.)
    Registration Number
    9680091
    FEI Number
    3002806830
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    104 SHORTING RD.
    City
    TORONTO Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K992732

    Owner / Operator

    Firm Name
    GENTELL
    Operator Number
    10026501
    Address
    180 Rittenhouse Circle,
    City
    Bristol
    State
    PA
    Postal Code
    19007
    Country
    US
    Correspondent
    Michael Alford

    US Agent

    Business Name
    GENTELL
    Contact Name
    Michael Alford
    Address
    1000 Floral Vale Blvd Ste 400
    City
    Morrisville
    State
    PA
    ZIP
    19067
    Country
    US
    Email
    [email protected]
    Phone
    800 8409041

    Products

    Device Name Product Code
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ

    Proprietary Names

    DUP48501N Sterile Saline 4 FL oz DUP48501 Sterile Saline 4 FL oz HP48502 Sterile Saline 2 FL oz DUP48802 Sterile Water 2 FL.OZ. HP48801 Sterile Water 4 FL.OZ. DUP48502 Sterile Saline 2 FL oz DUP48801 Sterile Water 4 FL.OZ. DUP48500 Sterile Saline 4 FL oz HP48802 Sterile Saline 2 FL oz HP48501 Sterile Saline 4 FL oz

    Establishment Types

    Manufacture Medical Device