Integra Canada ULC

FDA Device Registration & Listing · Oakville Ontario, CA · Registration 3012507533

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012507533
FEI Number
3012507533
Entity Name
Integra Canada ULC
City/State/Country
Oakville Ontario, CA
Establishment Address
2590 Bristol Circle, Unit 1, Oakville Ontario L6H 6Z7, CA
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Integra LifeSciences Corporation (Owner Number: 9004007)
Owner / Operator Contact Address
1100 Campus Rd, Princeton, NJ 08540, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Miltex Integra CODMAN VPV SYSTEM, MODEL 82-3192 Miltex Integra Jarit Miltex MicroFrance Integra CODMAN® ACCU-FLO® Straight Connector CODMAN® HOLTER® Padgett Integra Blade P4596 Integra LICOX PT02 Monitor MicroFrance Padgett Integra Miltex Jarit Integra MicroFrance Jarit MicroFrance Integra Miltex Padgett Mayfield Codman Electrosurgical Generator Codman Electrosurgical Foot Pedal Integra Miltex MicroFrance Jarit Carb-N-Sert Miltex Jarit Jarit Supercut Padgett CARB-EDGE Ruggles-Redmond METIS Padgett MicroFrance Integra Jarit Miltex Integra Miltex Integra Jarit Integra MicroFrance Cardio-Grip Miltex Jarit Carb-N-Sert Miltex Padgett Jarit Integra Integra Jarit Integra Miltex Ceram-A-Grip Miltex Petit-Point MicroFrance Jarit Padgett CARB-BITE Integra Jarit Supercut Jarit MicroFrance Ruggles-Redmond Padgett Miltex Integra Padgett Jarit MicroFrance Miltex Integra MicroFrance Jarit Miltex Integra Ruggles-Red Padgett Jarit Star Integra Petit-Pt Jarit Super CARB-BITE Miltex Jarit CARDIO-GRIP CARB-EDGE MicroFrance Jarit Integra CODMAN® HAKIM® Precision Fixed Pressure Valve CODMAN® HAKIM® Programmable Valve Integra Miltex Jarit Supercut Roto-Lok Roto-Cam Jarit MicroFrance Padgett Jarit Ruggles-Redmond Miltex Integra Padgett MicroFrance Miltex Integra Jarit MicroFrance Integra MicroFrance Integra 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 Miltex MicroFrance Integra Jarit Integra MicroFrance Jarit CUSA Excel+ Ultrasonic Surgical Aspirator System; C2623; C5623; CUSAEXCEL2; C2600; C5601; C5602 Jarit Miltex Codman® Electrosurgical lrrigator Codman® Electrosurgical Interconnecting Cable MicroFrance Jarit Integra MicroFrance Integra Jarit Jarit Miltex Thompson MicroFrance Padgett Jarit Miltex Integra LICOX BRAIN OXYGEN MONITORING SYSTEM CATHETER PROBES AND KIT Integra Miltex Jarit MicroFrance Integra Padgett Miltex Jarit Ruggles-Redmond Integra MicroFrance Integra Jarit Padgett MicroFrance Miltex Jarit Integra Integra Miltex Integra Jarit Probe 8" Integra Jarit Miltex MicroFrance Jarit Integra MicroFrance Integra Jarit Ruggles-Redmond Padgett Miltex Integra MicroFrance Galea Elevator Arkis Galea Elevator Padgett Jarit MicroFrance CARB-BITE Miltex Integra MicroFrance Padgett Jarit Miltex Integra 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 Jarit Miltex MicroFrance Integra MicroFrance Jarit Miltex Padgett Miltex Jarit 5-800 Jarit Miltex MicroFrance Integra Jarit 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 Jarit Integra Miltex Padgett MicroFrance Integra Luxtec MLX 300 Watt Xenon Light Integra Miltex Integra Jarit CODMAN CERTAS PLUS PROGRAMMAGLE VALVE SYSTEM Padgett Miltex Integra Jarit MicroFrance 33-52;33-53;33-54;33-55;33-57 Carb-N-Sert Miltex Integra MicroFrance Jarit Ruggles-Redmond Padgett Diamond Integra Jarit Integra CUSA Clarity Ultrasonic Surgical Aspirator System; C7023; C7123; C7623; C7601; C7601EA Integra Miltex MicroFrance Jarit CODMAN Bipolar Cords Jarit Padgett CARDIO-GRIP Miltex Ruggles-Redmond Integra Integra Luxtec DLX UltraLite Pro Camera System Integra Ruggles-Redmond Integra MicroFrance Integra Jarit CODMAN DISPOSABLE SCALP CLIP APPLIER Jarit Miltex CereLink ICP Replacement Power Supply 826822 CereLink ICP Extension Cable 826845 CereLink ICP Replacement Battery 826824 CereLink ICP Monitor 826820 Jarit Miltex Codman Instrument Tray Integra Integra Allograft Wedge Instrument Tray Assembly MicroFrance Miltex Jarit Integra Jarit LumbarTrak Ruggles-Redmond Miltex Jarit Miltex Padgett Miltex MicroFrance Jarit Integra Ruggles-Redmond Jarit Miltex CARB-BITE Jarit Ruggles-Redmond 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 Jarit Integra Miltex MicroFrance Hakim Percision Valve System Jarit Miltex Integra MicroFrance Jarit Integra Miltex MicroFrance Padgett Integra Ruggles-Redmond MicroFrance Jarit Miltex Integra Jarit Miltex MicroFrance Integra MicroFrance Integra Jarit Miltex MicroFrance Integra Jarit Ruggles-Redmond

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EFK Forceps, Articulation Paper Dental Class 1 872.4565 1981-04-24
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
EJI Syringe, Cartridge Dental Class 2 872.6770 2009-05-27
KBZ Snare, Tonsil Ear, Nose, Throat Class 1 874.4420 1981-04-24
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
FZW Expander, Surgical, Skin Graft General, Plastic Surgery Class 1 878.4800 2007-06-27
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2013-10-21
NNR Block, Cutting, Ent, Non-Sterile Ear, Nose, Throat Class 1 874.3540 2004-10-05
JYO Knife, Ear Ear, Nose, Throat Class 1 874.4420 1981-04-24
EPY Speculum, Ent General, Plastic Surgery Class 1 878.1800 1981-04-24
HBM Headrest, Neurosurgical Neurology Class 1 882.4440 2004-07-20
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-04-29
JYT Pick, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 1999-05-19
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2003-09-09
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2006-11-27
KBA Rasp, Nasal Ear, Nose, Throat Class 1 874.4420 2014-11-04
HCZ Forceps, Surgical, Gynecological Obstetrics/Gynecology Class 2 884.4530 2014-04-15
EFL Forceps, Dressing, Dental Dental Class 1 872.4565 2001-12-04
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2003-09-09
KBD Scissors, Nasal Ear, Nose, Throat Class 1 874.4420 1999-05-05
EIG Retractor, All Types Dental Class 1 872.4565 1981-04-24
FFO Retractor, Self-Retaining Gastroenterology, Urology Class 1 876.4730 1981-04-24
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 1981-04-24
JYH Excavator, Ear Ear, Nose, Throat Class 1 874.4420 2009-11-19
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
EJY Pliers, Operative Dental Class 1 872.4565 1981-04-24
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4160 2009-11-20
HTX Rongeur Orthopedic Class 1 888.4540 1981-04-24
KTG Knife, Ent Ear, Nose, Throat Class 1 874.4420 2003-08-05
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 1998-12-31
KAW Punch, Antrum Ear, Nose, Throat Class 1 874.4420 1981-04-24
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2017-09-26
JYR Nipper, Malleus Ear, Nose, Throat Class 1 874.4420 2007-01-18
GDM Needle, Aspiration And Injection, Reusable General, Plastic Surgery Class 1 878.4800 2003-07-07
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2015-02-20
HDL Retractor, Vaginal Obstetrics/Gynecology Class 1 884.4520 1981-04-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-11-30
KCB Tube, Tonsil Suction Ear, Nose, Throat Class 1 874.4420 2009-11-19
JYL Hook, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 2009-11-19
JEX Plier, Orthodontic Dental Class 1 872.4565 1981-04-24
KAE Forceps, Ent Ear, Nose, Throat Class 1 874.4420 1999-06-09
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2007-02-22
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 1981-04-24
KAD Elevator, Ent Ear, Nose, Throat Class 1 874.4420 1981-04-24
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2004-11-09
KAN Chisel, Nasal General, Plastic Surgery Class 1 878.4800 2004-11-09
FGM Probe And Director, Gastro-Urology Gastroenterology, Urology Class 1 876.4730 2003-09-04
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2014-06-04
KTF Punch, Ent Ear, Nose, Throat Class 1 874.4420 2003-08-05
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2015-01-19
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2015-01-19
GAD Retractor General, Plastic Surgery Class 1 878.4800 1981-04-24
GAC Rasp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1981-04-24
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2003-08-05
FBX Sound, Urethral, Metal Or Plastic Gastroenterology, Urology Class 1 876.5520 1981-04-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-06-17
KAK Probe, Ent Ear, Nose, Throat Class 1 874.4420 2000-10-17
LGG Instrument, Cast Application/Removal, Manual Orthopedic Class 1 888.5980 2003-09-04
HFB Forceps, Biopsy, Gynecological Obstetrics/Gynecology Class 1 884.4530 1981-04-24
KTE Trocar, Ent Ear, Nose, Throat Class 1 874.4420 2009-11-19
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-09-26
GFI Osteotome, Manual General, Plastic Surgery Class 1 878.4800 2003-08-05
FCW Light Source, Fiberoptic, Routine Gastroenterology, Urology Class 2 876.1500 2016-02-03
HCY Curette, Uterine Obstetrics/Gynecology Class 1 884.4530 2003-08-05
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2003-08-05
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1981-04-24
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2013-09-25
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2013-01-11
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2019-01-03
LBK Neurosurgical Ultrasonic Instruments Unknown Class U N/A 2019-01-03
JZF Tube, Ear Suction Ear, Nose, Throat Class 1 874.4420 1981-04-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-09-26
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2012-07-18
FWC Camera, Television, Surgical, With Audio General, Plastic Surgery Class 1 878.4160 2003-07-16
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2011-06-28
HYA Forceps, Wire Holding General, Plastic Surgery Class 1 878.4800 2009-11-19
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2014-06-04
HBO Clip, Scalp Neurology Class 2 882.4150 2017-09-26
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 1981-04-24
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2024-02-05
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2000-12-14
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 2000-10-24
HBG Drills, Burrs, Trephines & Accessories (Manual) Neurology Class 2 882.4300 2009-11-19
HDC Tenaculum, Uterine Obstetrics/Gynecology Class 2 884.4530 2009-01-20
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2000-12-14
HHM Sound, Uterine Obstetrics/Gynecology Class 1 884.4530 1981-04-24
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2005-03-24
HCA Catheter, Ventricular Neurology Class 2 882.4100 2024-03-13
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2024-03-13
JZB Scissors, Ear Ear, Nose, Throat Class 1 874.4420 1981-04-24
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
KBS Punch, Adenoid Ear, Nose, Throat Class 1 874.4420 1981-02-24
KAL Retractor, Ent Ear, Nose, Throat Class 1 874.4420 2003-08-05
KBN Gag, Mouth Ear, Nose, Throat Class 1 874.4420 1981-04-24
KBE Snare, Nasal Ear, Nose, Throat Class 1 874.4420 2003-09-04
JYK Holder, Ear Speculum General, Plastic Surgery Class 1 878.1800 1999-06-01
KAP Curette, Nasal Ear, Nose, Throat Class 1 874.4420 2003-08-05
GZX Instrument, Microsurgical Neurology Class 1 882.4525 1998-08-24

Official Correspondent

No official correspondent registered.

US Agent Details

Kerri DiPietro Business: Integra LifeSciences Corporation Email: kerri.dipietro@integralife.com Phone: (774) 7196909

Related Public Records

Same Entity

Integra LifeSciences Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3015194982 SURGICAL INNOVATION ASSOCIATES, INC. Chicago, IL, US
3013505638 REBOUND THERAPEUTICS, CORPORATION Irvine, CA, US
3006697299 INTEGRA LIFESCIENCES (IRELAND) LIMITED SRAGH TULLAMORE Offaly, IE
2648988 INTEGRA NEUROSCIENCES ANASCO, PR, US
9680837 INTEGRA MICROFRANCE SAS SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K071458 Integra LifeSciences Corporation MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS 2007-06-13
K981246 Integra Neurocare, LLC BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730) 1999-05-26
K020558 Integra Neurosciences LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE 2002-03-21
K834189 Imm Enterprises , Ltd. JAKOBI SURG. INSTRUMENTS #7 44/47 1984-03-06
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18

Related Recall Records

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Z-0031-06 Rita Medical Systems 2
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Z-0008-04 Rultract Inc 1
Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Z-0144-2024 Covidien 1
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024 Covidien 1
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024 Covidien 1
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012507533. Last updated year: 2026. Please use registration number 3012507533 when referencing this establishment in official correspondence.
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