BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    DUP9340 Gazetex 100% Cotton , 6-ply, Fluff Sponge 6" x 6I-3/4" Sterile

    Reg #: 9680091 · FEI: 3002806830 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    24
    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
    K946326

    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
    Gauze/Sponge, Internal EFQ

    Proprietary Names

    DUP9340 Gazetex 100% Cotton , 6-ply, Fluff Sponge 6" x 6I-3/4" Sterile DUP9333 Gazetex 100% Cotton , 6-ply, Fluff Sponge 6" x 6-3/4" Non -Sterile DUP77784 Dutex 100% Cotton 2 ply conforming Bandage 6" x 4.1 yd Sterile DUP75203 Duform Synthetic Conforming Bandage 3" x 4.1 yd Sterile DUP9320-48 Gazetex Bandage Rolls 4-1/2" x 4.1 yds, 6 ply Non-Sterile DUP77782 Dutex 100% Cotton 2 ply conforming Bandage 3" x 4.1 yd Sterile DUP77781 Dutex 100% Cotton 2 ply conforming Bandage 2" x 4.1 yd Sterile DUP75204 Duform Synthetic Conforming Bandage 4" x 4.1 yd Sterile DUP75206 Duform Synthetic Conforming Bandage 6" x 4.1 yd Sterile DUP9345 Gazetex 100% Cotton , 6-ply, Fluff Sponge 7-3/4" x 8-3/4" Sterile DUP76782 Dutex 100% Cotton 2 ply conforming Bandage 3" x 4.1 yd Non-Sterile DUP76781 Dutex 100% Cotton 2 ply conforming Bandage 2" x 4.1 yd Non-Sterile DUP76783 Dutex 100% Cotton 2 ply conforming Bandage 4" x 4.1 yd Non-Sterile DUP75106 Duform Synthetic Conforming Bandage 6" x 4.1 yd Non-Sterile DUP76784 Dutex 100% Cotton 2 ply conforming Bandage 6" x 4.1 yd Non-Sterile DUP77783 Dutex 100% Cotton 2 ply conforming Bandage 4" x 4.1 yd Sterile DUP9334 Gazetex 100% Cotton , 6-ply, Fluff Sponge 7-3/4" x 8-3/4" Non- Sterile DUP9322 Gazetex Bandage Rolls 4-1/2" x 4.1 yds, 6 ply Sterile DUP75202 Duform Synthetic Conforming Bandage 2" x 4.1 yd Sterile DUP75103 Duform Synthetic Conforming Bandage 3" x 4.1 yd Non-Sterile DUP75104 Duform Synthetic Conforming Bandage 4" x 4.1 yd Non-Sterile DUP9321 Gazetex Bandage Rolls 2-1/2" x 3 yds, 6 ply Sterile DUP75102 Duform Synthetic Conforming Bandage 2" x 4.1 yd Non-Sterile DUP9320 Gazetex Bandage Rolls 4-1/2" x 4.1 yds, 6 ply Non-Sterile

    Establishment Types

    Manufacture Medical Device