BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Integra Canada ULC

    Reg #: 3012507533 · FEI: 3012507533 · Expires 2026
    View on FDA
    Products
    110
    Proprietary Names
    114
    Establishment Types
    1
    Classifications
    110

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    Registration Details

    Registration Name
    Integra Canada ULC
    Registration Number
    3012507533
    FEI Number
    3012507533
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2590 Bristol Circle, Unit 1
    City
    Oakville Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K061876
    PMA Number
    P080013

    Owner / Operator

    Firm Name
    Integra LifeSciences Corporation
    Operator Number
    9004007
    Address
    1100 Campus Rd
    City
    Princeton
    State
    NJ
    Postal Code
    08540
    Country
    US

    US Agent

    Business Name
    Integra LifeSciences Corporation
    Contact Name
    Kerri DiPietro
    Address
    11 Cabot Blvd
    City
    Mansfield
    State
    MA
    ZIP
    02048
    Country
    US
    Email
    [email protected]
    Phone
    774 7196909

    Products

    Device Name Product Code
    Forceps, Articulation Paper EFK
    Shunt, Central Nervous System And Components JXG
    Syringe, Cartridge EJI
    Snare, Tonsil KBZ
    Expander, Surgical, Skin Graft FZW
    Device, Monitoring, Intracranial Pressure GWM
    Block, Cutting, Ent, Non-Sterile NNR
    Knife, Ear JYO
    Speculum, Ent EPY
    Headrest, Neurosurgical HBM
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Pick, Microsurgical Ear JYT
    Scissors, Ophthalmic HNF
    Osteotome HWM
    Rasp, Nasal KBA
    Forceps, Surgical, Gynecological HCZ
    Forceps, Dressing, Dental EFL
    Holder, Needle, Gastroenterologic FHQ
    Scissors, Nasal KBD
    Retractor, All Types EIG
    Retractor, Self-Retaining FFO
    Instruments, Surgical, Cardiovascular DWS
    Excavator, Ear JYH
    Pliers, Operative EJY
    Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) KNF
    Rongeur HTX
    Knife, Ent KTG
    Laryngoscope, Rigid CCW
    Punch, Antrum KAW
    Nipper, Malleus JYR
    Needle, Aspiration And Injection, Reusable GDM
    Instrument, Ultrasonic Surgical LFL
    Retractor, Vaginal HDL
    Tube, Tonsil Suction KCB
    Hook, Microsurgical Ear JYL
    Plier, Orthodontic JEX
    Forceps, Ent KAE
    Cutter, Surgical FZT
    Elevator, Ent KAD
    Instrument, Ent Manual Surgical LRC
    Chisel, Nasal KAN
    Probe And Director, Gastro-Urology FGM
    Laparoscope, General & Plastic Surgery GCJ
    Punch, Ent KTF
    Laparoscope, Gynecologic (And Accessories) HET
    Retractor GAD
    Rasp, Surgical, General & Plastic Surgery GAC
    Punch, Surgical LRY
    Sound, Urethral, Metal Or Plastic FBX
    Probe, Ent KAK
    Instrument, Cast Application/Removal, Manual LGG
    Forceps, Biopsy, Gynecological HFB
    Trocar, Ent KTE
    Osteotome, Manual GFI
    Light Source, Fiberoptic, Routine FCW
    Curette, Uterine HCY
    Curette, Surgical, General Use FZS
    Forceps, General & Plastic Surgery GEN
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Neurosurgical Ultrasonic Instruments LBK
    Tube, Ear Suction JZF
    Clamp, Vascular DXC
    Camera, Television, Surgical, With Audio FWC
    Forceps, Wire Holding HYA
    Clip, Scalp HBO
    Speculum, Vaginal, Metal HDF
    Tray, Surgical, Instrument FSM
    Hook, Ophthalmic HNQ
    Drills, Burrs, Trephines & Accessories (Manual) HBG
    Tenaculum, Uterine HDC
    Dissector, Surgical, General & Plastic Surgery GDI
    Sound, Uterine HHM
    Orthopedic Manual Surgical Instrument LXH
    Catheter, Ventricular HCA
    Scissors, Ear JZB
    Punch, Adenoid KBS
    Retractor, Ent KAL
    Gag, Mouth KBN
    Snare, Nasal KBE
    Holder, Ear Speculum JYK
    Curette, Nasal KAP
    Instrument, Microsurgical GZX
    Rongeur, Nasal KBB
    Hook, Surgical, General & Plastic Surgery GDG
    Tray, Surgical, Ent MMO
    Catheter And Tip, Suction JOL
    Syringe, Irrigating (Non Dental) KYZ
    Twister, Wire HXS
    Tube, Laryngectomy KAC
    Rongeur, Mastoid JZA
    Instrument, Ligature Passing And Knot Tying HCF
    Curette, Ear JYG
    Forceps HTD
    Elevator, Surgical, General & Plastic Surgery GEG
    Instrument, Cutting, Orthopedic HTZ
    Curette, Periodontic EMS
    Depressor, Metal Tongue, Surgical KBL
    Scissors, General, Surgical LRW
    Speculum, Rectal FFQ
    Blade, Scalpel GES
    Sealant, Dural NQR
    Instrument, Surgical, Non-Powered HAO
    Instrument, Manual, Surgical, General Use MDM
    Forceps, Obstetrical HDA
    Rongeur, Manual HAE
    Retainer, Matrix JEP
    Punch, Nasal KAY
    Hemostat HRQ
    Forceps, Ophthalmic HNR
    Handle, Scalpel GDZ

    Proprietary Names

    Miltex Integra CODMAN VPV SYSTEM, MODEL 82-3192 Jarit MicroFrance CODMAN® ACCU-FLO® Straight Connector CODMAN® HOLTER® Padgett Blade P4596 Integra LICOX PT02 Monitor Mayfield Codman Electrosurgical Generator Codman Electrosurgical Foot Pedal Carb-N-Sert Jarit Supercut CARB-EDGE Ruggles-Redmond METIS Integra Miltex Integra Jarit Cardio-Grip Ceram-A-Grip Petit-Point CARB-BITE Ruggles-Red Jarit Star Petit-Pt Jarit Super CARDIO-GRIP CODMAN® HAKIM® Precision Fixed Pressure Valve CODMAN® HAKIM® Programmable Valve Roto-Lok Roto-Cam Codman Microsensor Metal Skull Bolt Kit Codman Microsensor Ventricular Catheter Kit Codman Microsensor Plastic Skull Bolt Kit Codman Microsensor Ventricular Catheter Kit With Tuohyborst Adapter Codman Microsensor Basic Kit CUSA Excel+ Ultrasonic Surgical Aspirator System; C2623; C5623; CUSAEXCEL2; C2600; C5601; C5602 Codman® Electrosurgical lrrigator Codman® Electrosurgical Interconnecting Cable Thompson LICOX BRAIN OXYGEN MONITORING SYSTEM CATHETER PROBES AND KIT Probe 8" Galea Elevator Arkis Galea Elevator 33-34-SH;33-35;33-35-SH;33-36;33-36-SH;33-37;33-38 33-31;33-31A;33-31AA;33-31AA-P/25;33-31A-P/25;33-31B;33-31-P/25;33-32;33-32-P/25;33-33;33-33-SH;33-34;33-34-P/25 5-800 CODMAN Mirror Finish Bipolar Forceps CODMAN Spetzler Mirror Finish Bipolar Forceps CODMAN MALIS Mirror Finish Bipolar Forceps CODMAN RHOTON Mirror Finish Bipolar Forceps CODMAN® YASARGIL Mirror Finish Bipolar Forceps Integra Luxtec MLX 300 Watt Xenon Light CODMAN CERTAS PLUS PROGRAMMAGLE VALVE SYSTEM 33-52;33-53;33-54;33-55;33-57 Diamond CUSA Clarity Ultrasonic Surgical Aspirator System; C7023; C7123; C7623; C7601; C7601EA CODMAN Bipolar Cords Integra Luxtec DLX UltraLite Pro Camera System CODMAN DISPOSABLE SCALP CLIP APPLIER CereLink ICP Replacement Power Supply 826822 CereLink ICP Extension Cable 826845 CereLink ICP Replacement Battery 826824 CereLink ICP Monitor 826820 Codman Instrument Tray Integra Allograft Wedge Instrument Tray Assembly LumbarTrak Integra Anti-Rotation Peg Holder Integra Allograft Wedge Sizer Instrument Integra Allograft Wedge Instrument Set Bactiseal Catheters Bactiseal Barium Striped Catheters Bactiseal Endoscopic Ventricular Catheter Hakim Percision Valve System CODMAN® HAKIM® Valve Programmer CODMAN EDS 3 - CSF External Drainage System CUSA Clarity Ultrasonic Surgical Aspirator System; C7602; C7602EA HAKIM PROGRAMMABLE VALVE SYSTEM HAKIM MICRO PROGRAMMABLE VALVE SYSTEM SiphonGuard TM CSF Control Device HAKIM PRECISION VALVE SYSTEM GENERAL INSTRUMENT 5-700;5-702;5801;5803;5804 CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps 4-322;4-323;4-325;4610;4611;4615 4-110;4-111;4-112;4-112B;4-115;4-115C;4-120;4-121;4-122;4-123;4-125;4-310;4-311;4-312;4-312B;4-315;4-315C;4-320;4-321 DuraSeal Exact Dural Sealant Codman Ventricular Needles Subcutaneous Guidewire Arkis Subcutaneous Guideware Wing-Grip CODMAN Disposable Tunneler for Subcutaneous Placement of Catheters Arkis Subcutaneous Guidewire Loop Canulator / Canulator CUSA EXCEL Ultrasonic Surgical Aspirator System CereLink ICP Sensor Certas Plus Programmable Valve Alleghany CSF External Drainage Sys Pudenz Catheters Integra Reservoirs Braden Reservoir Pudenz Peritoneal Catheter Mishler Valve Systems Hermetic External CSF Drainage Syst Pudenz Valves On-Off Flushing Valves Multi-Purpose Valves External CSF Drainage Systems Pudenz Cardiac Catheters Codman External Drainage System II

    Establishment Types

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