BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    69201 Primaderm Dermal Wound Cleanser 16 fl oz Spray Bottle Non Sterile

    Reg #: 9680091 · FEI: 3002806830 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    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
    K954743

    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
    Dressing, Wound, Drug FRO

    Proprietary Names

    69201 Primaderm Dermal Wound Cleanser 16 fl oz Spray Bottle Non Sterile Zinc Wound Wash First Aid Cleanser WC-04 DermaGran Wound Cleanser with Zinc 4 oz 69101 Primaderm Dermal Wound Cleanser 4.15oz 69202 Primaderm Dermal Wound Cleanser 4.15oz Non Sterile

    Establishment Types

    Manufacture Medical Device