BEUDAMED
    FDA Registration Active 🇺🇸 United States

    7051395 CANADA INC DBA HTA DIRECT SOURCING

    Reg #: 3009518015 · FEI: 3009518015 · Expires 2026
    View on FDA
    Products
    35
    Proprietary Names
    38
    Establishment Types
    2
    Classifications
    35

    Registration Details

    Registration Name
    7051395 CANADA INC DBA HTA DIRECT SOURCING
    Registration Number
    3009518015
    FEI Number
    3009518015
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    102 West Service Road, Unit 047
    City
    Champlain
    State
    NY
    ZIP
    12919
    Country
    US

    Regulatory Submissions

    510(k) Number
    K033603
    PMA Number
    P080011

    Owner / Operator

    Firm Name
    7051395 Canada Inc Dba HTA Direct Sourcing
    Operator Number
    10084602
    Address
    102 West Service Road, Unit 1047
    City
    Champlain
    State
    NY
    Postal Code
    12919
    Country
    US

    Products

    Device Name Product Code
    Frame, Trial, Ophthalmic HPA
    Calibrator, Secondary JIT
    Radioassay, Intrinsic Factor Blocking Antibody LIG
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Lenses, Soft Contact, Daily Wear LPL
    Lens, Contact, (Disposable) MVN
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Pad, Eye HMP
    Radioimmunoassay, Estradiol CHP
    Calibrator, Primary JIS
    Radioimmunoassay, Free Thyroxine CEC
    Refractor, Manual, Non-Powered, Including Phoropter HKN
    Tape And Bandage, Adhesive KGX
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Set, Administration, Intravascular FPA
    Instrument, Manual, Surgical, General Use MDM
    Lenses, Soft Contact, Extended Wear LPM
    Prosthesis, Elbow, Constrained, Cemented JDC
    Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine KLI
    Radioimmunoassay (Two-Site Solid Phase), Ferritin JMG
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW
    Acid, Folic, Radioimmunoassay CGN
    Radioassay, Vitamin B12 CDD
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Ferritin, Antigen, Antiserum, Control DBF
    Prism, Bar, Ophthalmic HKW
    Mask, Scavenging KHA
    Set, Lens, Trial, Ophthalmic HPC
    System, Test, Vitamin D MRG
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Radioimmunoassay, Parathyroid Hormone CEW
    Tube Tracheostomy And Tube Cuff JOH
    Applicator, Absorbent Tipped, Sterile KXG
    Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) JKC
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    Trial Frame Single (specified) analyte controls (assayed and unassayed) Calibrator, secondary 3014233026 Foreign Exporter RADIOASSAY, INTRINSIC FACTOR BLOCKING ANTIBODY Lenses, soft contact, daily wear Lens, contact, (disposable) NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) PAD, EYE RADIOIMMUNOASSAY, ESTRADIOL Calibrator, primary 100566RADIOIMMUNOASSAY, FREE THYROXINE Phoropter TAPE AND BANDAGE, ADHESIVE Set, administration, intravascular Tubes, vials, systems, serum separators, blood collection Instrument Tip Protectors Lenses, soft contact, extended wear PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED Enzyme immunoassay, non-radiolabeled, total thyroxine Calibrator, secondary Radioimmunoassay (two-site solid phase), ferritin Radioassay, vitamin b12 ACID, FOLIC, RADIOIMMUNOASSAY RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE),FOR CLINICAL USE Ferritin, antigen, antiserum, control ens, contact, (disposable) 3014233026 Foreign Exporter Prism Bar MASK, SCAVENGING PAD, ALCOHOL, DEVICE DISINFECTANT TRIAL LENS SET SYSTEM, TEST, VITAMIN D Post Mydriatic Eyewear RADIOIMMUNOASSAY, PARATHYROID HORMONE Tube tracheostomy and tube cuff Ophthalmic prism bar RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE) Needle, hypodermic, single lumen

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198