BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    EIKON DEVICE INC.

    Reg #: 3010363542 · FEI: 3010363542 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    53
    Establishment Types
    1
    Classifications
    19

    Registration Details

    Registration Name
    EIKON DEVICE INC.
    Registration Number
    3010363542
    FEI Number
    3010363542
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    689 Innovation Drive
    City
    Kingston Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K071740

    Owner / Operator

    Firm Name
    Eikon Device Inc.
    Operator Number
    10044469
    Address
    689 Innovation Drive
    City
    Kingston
    State
    Ontario
    Postal Code
    K7K7E6
    Country
    CA
    Correspondent
    Dean Byrnes

    Products

    Device Name Product Code
    Gauze / Sponge,Nonresorbable For External Use NAB
    Polymer Patient Examination Glove LZA
    Latex Patient Examination Glove LYY
    Bandage, Elastic FQM
    Bedding, Disposable, Medical KME
    Vinyl Patient Examination Glove LYZ
    Dressing, Wound, Hydrophilic NAC
    Indicator, Physical/Chemical Sterilization Process JOJ
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Wrap, Sterilization FRG
    Tape And Bandage, Adhesive KGX
    Gown, Examination FME
    Mask, Surgical FXX
    Fentanyl And Other Opioid Protection Glove QDO
    Medical Glove, Specialty LZC
    Marker, Skin FZZ
    Applicator, Ent KCJ
    Razor, Surgical LWK
    Absorber, Saliva, Paper KHR

    Proprietary Names

    Medicom Non-Sterile Gauze - pkg. 200 Dynarex PowderFree Nitrile Gloves - S, M, L, XL Dynarex PowderFree Latex Gloves - S, M, L, XL Eikon Wraps - Latex Free - 1” Camo Pack - Box of 24 Eikon Wraps - Latex Free - 2” Black Pack - Box of 12 Dynarex Self-Adherent Bandage Retainers Eikon Wraps - Latex Free - 1” Black Pack - Box of 24 Eikon Wraps - Latex Free - 2” Camo Pack - Box of 12 Dynarex Non-Adherent Pad - 17" x 24" Graham FlexAir Plus Disposable Pillow - case of 50 Graham pillowcase Tissue/Poly - blue - case of 100 Eikon Drape Sheet - 40 x 60 - Studio Grey Eikon Bib - 13 x 18 - Medical Blue Eikon Bib - 13 x 18 - Medical Blue - Case of 500 Eikon Bib - 13 x 18 - Studio Grey - Case of 500 Eikon Drape Sheet - 40 x 60 - Medical Blue Eikon Drape Sheet - 40 x 48 Eikon Drape Sheet - 40 x 48 - Studio Grey Eikon Bib - 13 x 18 - Studio Grey - Bag of 125 Dynarex PowderFree Vinyl Gloves - S, M, L, XL Defend PowderFree Latex Gloves - XS, S, M, L, XL Precision Violet Nitrile Gloves - XS, S, M, L, XL Black Lightning Nitrile Gloves - S, M, L, XL, XXL Shadow & Night Angel PowderFree Nitrile Gloves - XS, S, M, L, XL MicroFlex MidKnight Nitrile Gloves - XS, S, M, L, XL Eikon Premium Black Nitrile Powder Free Examination Gloves (XS, S, M, L, XL) Eikon Standard Premium Nitrile Powder Free Examination Gloves (XS, S, M, L, XL) Dynarex Non-Adherent Bandage - Sterile - 3" x 8" - box of 50 Crosstex Indicator Strip Black Lightning Gloves - Small, Medium Crosstex Sterilization Pouches Defend Sterilization Pouch - 2 1/4" x 4" Defend Sterilization Pouch - 3 1/2" x 10" Defend Sterilization Pouch - 2" x 7 3/4" Defend Sterilization Pouch - 3 1/2" x 5 1/4" Defend Sterilization Pouch - 5 1/4" x 10" Defend Sterilization Pouch - 2 3/4" x 10" Tatu-Derm Bandage 3M Micropore & Transpore Tape Dynarex Tape Saniderm Graham drape sheet Defend Breathe-EZ Mask Koda Glove Vitex Stretch Vinyl Gloves - XS, S, M, L, XL Securline Surgical Marker Viscot Mini XL Skin Marker Eikon Cat # 2313-all Dynarex PowderFree Latex Gloves Dynarex Tongue Depressors - 500/box Phantom PowderFree Latex Gloves - S, M, L, XL Medicom Safemask Premier - Blue - box of 50 Twin Blade Disposable Razors Blue - box of 50 Medicom Dental Bibs - case of 500

    Establishment Types

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