Disposable Surgical Instrument Kit Suppliers
Limit companies to: Worldwide USA
Staar Surgical Company | Address: 1911 Walker Ave., Monrovia, California 91016, USA 
www.staar.com | Send Inquiry | Phone: +1-(626)-303-7902
FDA Registration: 2023826 Year Established: 1982 Annual Revenues: USD 1-5 Million Employee Count: ~230 Quality: CE Certified
Products: Phacoemulsification Systems, Tube Shunt Surgery (Implants), IOL Inserters, Irrigation/Aspiration Systems, Viscosurgical Devices (Viscoelastics), Silicone IOLs, ...
Staar Surgical Company manufactures and distributes medical devices for use in cataract, refractive & glaucoma surgery. Our product line includes silicone & Collamer® foldable intraocular lenses, more...
www.staar.com | Send Inquiry | Phone: +1-(626)-303-7902
FDA Registration: 2023826 Year Established: 1982 Annual Revenues: USD 1-5 Million Employee Count: ~230 Quality: CE Certified
Products: Phacoemulsification Systems, Tube Shunt Surgery (Implants), IOL Inserters, Irrigation/Aspiration Systems, Viscosurgical Devices (Viscoelastics), Silicone IOLs, ...
Staar Surgical Company manufactures and distributes medical devices for use in cataract, refractive & glaucoma surgery. Our product line includes silicone & Collamer® foldable intraocular lenses, more...
Magnum Medical Sales, Inc. | Address: 395 Josefa St, San Jose, California 95126, USA
www.magnummedical.net | Send Inquiry | Phone: +1-(408)-294-1397
FDA Registration: 1421307 Year Established: 1984 Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: Maintenance & Repair, Disposable Surgical Instrument (FDA Code: KDC), Disposable Surgical Instrument Kit (FDA Code: KDD), General Surgical Manual Instrument (FDA Code: MDM), ENT Manual Surgical Instrument (FDA Code: LRC), Laryngoscope/Nasopharyngoscope (FDA Code: EQN), ...
Magnum Medical Sales, Inc. performs system maintenance, leak testing and installation of new med-gas systems. We also render repairing services for portable analgesia machines and regulators. more...
www.magnummedical.net | Send Inquiry | Phone: +1-(408)-294-1397
FDA Registration: 1421307 Year Established: 1984 Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: Maintenance & Repair, Disposable Surgical Instrument (FDA Code: KDC), Disposable Surgical Instrument Kit (FDA Code: KDD), General Surgical Manual Instrument (FDA Code: MDM), ENT Manual Surgical Instrument (FDA Code: LRC), Laryngoscope/Nasopharyngoscope (FDA Code: EQN), ...
Magnum Medical Sales, Inc. performs system maintenance, leak testing and installation of new med-gas systems. We also render repairing services for portable analgesia machines and regulators. more...
Denver Biomedical, Inc. | Address: 14998 West 6th Avenue, Bldg E-700, Golden, Colorado 80401, USA
www.denverbiomedical.com | Send Inquiry | Phone: +1-(303)-279-7500
Annual Revenues: USD 10-25 Million Employee Count: ~40 Quality: ISO 9001, CE Certified
Products: Pleurex Catheter, Drainage Line Set, Double-Valved Ascites Shunt, Nylon Tubing Connector, Pleural Effusion Shunt, Pleural Effusion Shunt with External Pump Chamber, ...
Denver Biomedical Inc. (DBI) is a leading designer, manufacturer and distributor of specialized medical products for fluid management of pleural effusion and ascites. Our Pleurx pleural catheter and t more...
www.denverbiomedical.com | Send Inquiry | Phone: +1-(303)-279-7500
Annual Revenues: USD 10-25 Million Employee Count: ~40 Quality: ISO 9001, CE Certified
Products: Pleurex Catheter, Drainage Line Set, Double-Valved Ascites Shunt, Nylon Tubing Connector, Pleural Effusion Shunt, Pleural Effusion Shunt with External Pump Chamber, ...
Denver Biomedical Inc. (DBI) is a leading designer, manufacturer and distributor of specialized medical products for fluid management of pleural effusion and ascites. Our Pleurx pleural catheter and t more...
Autosuture | Address: 150 Glover Avenue, Norwalk, Connecticut 06856, USA
www.autosuture.com | Send Inquiry | Phone: +1-(800)-722-8772
Annual Revenues: > USD 1 Billion Employee Count: ~5780 Quality: ISO 9001, ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Retractors, Scissors, Meniscal Repair Systems, Absorbable Suture Anchors, Suture Anchors, ...
Autosuture offers a complete line of surgical products and instrumentation that surgeons utilize for laparoscopic, endoscopic & traditional open surgical procedures & lymphatic mapping. We are an ISO more...
www.autosuture.com | Send Inquiry | Phone: +1-(800)-722-8772
Annual Revenues: > USD 1 Billion Employee Count: ~5780 Quality: ISO 9001, ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Retractors, Scissors, Meniscal Repair Systems, Absorbable Suture Anchors, Suture Anchors, ...
Autosuture offers a complete line of surgical products and instrumentation that surgeons utilize for laparoscopic, endoscopic & traditional open surgical procedures & lymphatic mapping. We are an ISO more...
Remington Medical, Inc. | Address: 6830 Meadowridge Court, Alpharetta, Georgia 30005, USA
www.remmed.com | Send Inquiry | Phone: +1-(800)-989-0057
FDA Registration: 3001676837
Products: Brachytherapy, Implant Needles, Alligator Clips, Bone Marrow Biopsy Needle, Aspiration Biopsy Needles, Biopsy Trays, Bag Decanters, ...
Remington Medical Inc. manufactures and distributes disposable medical products such as cardiovascular pacing cables & adapters, core tissue biopsy, aspiration biopsy, brachytherapy, introducer, bone more...
www.remmed.com | Send Inquiry | Phone: +1-(800)-989-0057
FDA Registration: 3001676837
Products: Brachytherapy, Implant Needles, Alligator Clips, Bone Marrow Biopsy Needle, Aspiration Biopsy Needles, Biopsy Trays, Bag Decanters, ...
Remington Medical Inc. manufactures and distributes disposable medical products such as cardiovascular pacing cables & adapters, core tissue biopsy, aspiration biopsy, brachytherapy, introducer, bone more...
Vyaire Medical, Inc. | Address: 26125 North Riverwoods Blvd, Mettawa, Illinois 60045, USA
www.vyaire.com | Send Inquiry | Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001 Annual Revenues: USD 50-100 Million Employee Count: ~230 Quality: ISO 9001, CE Certified
Products: Speech & Testing Equipment, Impedance Testing Systems, Audiometers & Accessories, Evoked Response Testing Systems, Infant Screening & Testing Units, Otoacoustic Emission Test Equipment, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l more...
www.vyaire.com | Send Inquiry | Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001 Annual Revenues: USD 50-100 Million Employee Count: ~230 Quality: ISO 9001, CE Certified
Products: Speech & Testing Equipment, Impedance Testing Systems, Audiometers & Accessories, Evoked Response Testing Systems, Infant Screening & Testing Units, Otoacoustic Emission Test Equipment, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l more...
Cook Group Incorporated | Address: P.O. Box 489, Bloomington, Indiana 47402-0489, USA
www.cookgroup.com | Phone: +1-(812)-339-2235, 800-457-4500
FDA Registration: 1820334 Employee Count: ~340 Quality: ISO 9000, CE Certified
Products: Ansel Modification, Balloon Catheters, Ansel Modification ANL Curve, Areolar Connective Tissue Grafts In Pediatric, Drug Clinical Trial Service, Centimeter Sizing Catheters, ...
Cook Group Incorporated focuses on the research and product development in minimally invasive medical device technology for diagnostic & therapeutic procedures. Our wire-guided arndt endobronchial blo more...
www.cookgroup.com | Phone: +1-(812)-339-2235, 800-457-4500
FDA Registration: 1820334 Employee Count: ~340 Quality: ISO 9000, CE Certified
Products: Ansel Modification, Balloon Catheters, Ansel Modification ANL Curve, Areolar Connective Tissue Grafts In Pediatric, Drug Clinical Trial Service, Centimeter Sizing Catheters, ...
Cook Group Incorporated focuses on the research and product development in minimally invasive medical device technology for diagnostic & therapeutic procedures. Our wire-guided arndt endobronchial blo more...
Cook Urological | Address: 1100 West Morgan Street,P.O. Box 227, Spencer, Indiana 47460, USA
www.cookurological.com | Phone: +1-(812)-829-4891
FDA Registration: 1825146
Products: Airway Management, ET Tubes, Airway Management, Adult Bronchoscope, Airway Management, Fiber Bronchoscope, Airway Management, Pediatric Bronchoscope, Airway Management, 3 Or Three Way Foley Catheter, ...
Cook Urological provides professionals in urological health care with medical products, employing the minimally invasive diagnostic and therapeutic device technologies, already proven clinically in ca more...
www.cookurological.com | Phone: +1-(812)-829-4891
FDA Registration: 1825146
Products: Airway Management, ET Tubes, Airway Management, Adult Bronchoscope, Airway Management, Fiber Bronchoscope, Airway Management, Pediatric Bronchoscope, Airway Management, 3 Or Three Way Foley Catheter, ...
Cook Urological provides professionals in urological health care with medical products, employing the minimally invasive diagnostic and therapeutic device technologies, already proven clinically in ca more...
Ranfac Corp. | Address: 30 Doherty Avenue, P.O. Box 635, Avon, Massachusetts 02322, USA
www.ranfac.com | Send Inquiry | Phone: +1-(508)-588-4400, (800)-272-6322
FDA Registration: 3011555966 Year Established: 1888 Annual Revenues: USD 10-25 Million Employee Count: ~50 Quality: ISO, CE Certified
Products: Stainless Steel Brain Biopsy Needles, Cholangiography Catheters (FDA Code: GBZ), Pneumoperitoneum Insufflation Needle, Multipurpose Knot Pusher Ligator, Soft Tissue Biopsy Needles, Percutaneous Introducer, ...
Ranfac Corp. supplies precision medical instruments for surgeons, radiologists and hematologists. Our product list comprises of disposable cholangiography catheters, percutaneous introducers, galactog more...
www.ranfac.com | Send Inquiry | Phone: +1-(508)-588-4400, (800)-272-6322
FDA Registration: 3011555966 Year Established: 1888 Annual Revenues: USD 10-25 Million Employee Count: ~50 Quality: ISO, CE Certified
Products: Stainless Steel Brain Biopsy Needles, Cholangiography Catheters (FDA Code: GBZ), Pneumoperitoneum Insufflation Needle, Multipurpose Knot Pusher Ligator, Soft Tissue Biopsy Needles, Percutaneous Introducer, ...
Ranfac Corp. supplies precision medical instruments for surgeons, radiologists and hematologists. Our product list comprises of disposable cholangiography catheters, percutaneous introducers, galactog more...
Genzyme Biosurgery | Address: 500 Kendall Street, Cambridge, Massachusetts 02142, USA
www.genzymebiosurgery.com | Send Inquiry | Phone: +1-(617)-252-7500
FDA Registration: 2246315 Employee Count: ~10000 Quality: CE Certified
Products: Hernia Repair Grafts, Arthritis Treatments, Miscellaneous Injectables, Vitamins & Minerals (Pediatric/Adult), Surgical Mesh, Hernia Repair Grafts, Alternative Arthritis Treatments, ...
Genzyme Biosurgery develops novel biotherapeutic and biomaterial products. Our products and research pipeline harness the power of biology to improve the health of patients in the orthopaedics & post- more...
www.genzymebiosurgery.com | Send Inquiry | Phone: +1-(617)-252-7500
FDA Registration: 2246315 Employee Count: ~10000 Quality: CE Certified
Products: Hernia Repair Grafts, Arthritis Treatments, Miscellaneous Injectables, Vitamins & Minerals (Pediatric/Adult), Surgical Mesh, Hernia Repair Grafts, Alternative Arthritis Treatments, ...
Genzyme Biosurgery develops novel biotherapeutic and biomaterial products. Our products and research pipeline harness the power of biology to improve the health of patients in the orthopaedics & post- more...
Scanlan International | Address: One Scanlan Plaza, St. Paul, Minnesota 55107, USA
www.scanlaninternational.com | Send Inquiry | Phone: +1-(651)-298-0997, 800-328-9458
FDA Registration: 2126670 Year Established: 1921 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Clamps, Scissors, Vascular Clamps (FDA Code: DXC), Micro Surgery Instruments, Scissors, Surgical Scissors, Cartilage Scissors, ...
Scanlan International designs and manufactures surgical instrumentation. Our product categories are cardiac/vascular, neurosurgical, single-use products, instrument care and custom design. Our Scanlan more...
www.scanlaninternational.com | Send Inquiry | Phone: +1-(651)-298-0997, 800-328-9458
FDA Registration: 2126670 Year Established: 1921 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Clamps, Scissors, Vascular Clamps (FDA Code: DXC), Micro Surgery Instruments, Scissors, Surgical Scissors, Cartilage Scissors, ...
Scanlan International designs and manufactures surgical instrumentation. Our product categories are cardiac/vascular, neurosurgical, single-use products, instrument care and custom design. Our Scanlan more...
Gotham Medical LLC | Address: 725 River Road, Suite 32-254, Edgewater, New Jersey 07020, USA
www.gothammedical.com | Send Inquiry | Phone: +1-(201)-608-7169
Products: Bone Taps (FDA Code: HWX), Bone Mill (FDA Code: LYS), Bender (FDA Code: HXW), Bone Cap (FDA Code: JDT), Bone Screw Starter (FDA Code: HWD), Compression Instrument (FDA Code: HWN), ...
Gotham Medical LLC designs, manufactures and markets ultimate orthopedic trauma & reconstruction products. We have different internal & external bone fixation solutions to fix the bone fractures and t more...
www.gothammedical.com | Send Inquiry | Phone: +1-(201)-608-7169
Products: Bone Taps (FDA Code: HWX), Bone Mill (FDA Code: LYS), Bender (FDA Code: HXW), Bone Cap (FDA Code: JDT), Bone Screw Starter (FDA Code: HWD), Compression Instrument (FDA Code: HWN), ...
Gotham Medical LLC designs, manufactures and markets ultimate orthopedic trauma & reconstruction products. We have different internal & external bone fixation solutions to fix the bone fractures and t more...
Ethicon, Inc. | Address: P.O. Box 151,Route 22 West, Somerville, New Jersey 08876, USA
www.ethicon.com | Send Inquiry | Phone: +1-(800)-888-9234
FDA Registration: 3003702646 Employee Count: ~9000
Products: Absorbable Suture Anchors, Absorbable Surgical Sutures, Absorbable Hemostats Surgicel, 80° Vertical Microscissors, Absorbable Adhesion Barrier (FDA Code: MCN), Absorbable Laparoscopy Suture, ...
Ethicon, Inc. is a global medical device company, which specializes in surgical sutures. Our product portfolio comprises of aesthetic medicine, biosurgicals, hernia solutions, infection control, pelvi more...
www.ethicon.com | Send Inquiry | Phone: +1-(800)-888-9234
FDA Registration: 3003702646 Employee Count: ~9000
Products: Absorbable Suture Anchors, Absorbable Surgical Sutures, Absorbable Hemostats Surgicel, 80° Vertical Microscissors, Absorbable Adhesion Barrier (FDA Code: MCN), Absorbable Laparoscopy Suture, ...
Ethicon, Inc. is a global medical device company, which specializes in surgical sutures. Our product portfolio comprises of aesthetic medicine, biosurgicals, hernia solutions, infection control, pelvi more...
Medical Action Industries Inc. | Address: 800 Prime Place, Hauppauge, New York 11788, USA
www.medical-action.com | Send Inquiry | Phone: +1-(631)-231-4600
FDA Registration: 1030451 Year Established: 1977
Products: Analgesics, Antibiotics & Antibacterials, Approved Chemotherapy Containers, Absorbable Hemostats Surgicel, Adhesive Felt, Arm Dressing, ...
Medical Action Industries Inc. develops & distributes a variety of disposable surgical-related products. We manufacture & distribute operating room disposable supplies, containment systems for medical more...
www.medical-action.com | Send Inquiry | Phone: +1-(631)-231-4600
FDA Registration: 1030451 Year Established: 1977
Products: Analgesics, Antibiotics & Antibacterials, Approved Chemotherapy Containers, Absorbable Hemostats Surgicel, Adhesive Felt, Arm Dressing, ...
Medical Action Industries Inc. develops & distributes a variety of disposable surgical-related products. We manufacture & distribute operating room disposable supplies, containment systems for medical more...
GI Supply | Address: 200 Grandview Avenue, Camp Hill, Pennsylvania 17011-1706, USA
www.gi-supply.com | Send Inquiry | Phone: +1-(717)-761-1170
FDA Registration: 2529592 Quality: CE Certified
Products: Helicobacter pylori Urease Test Kits, Surgical Gowns (FDA Code: FYA), Fluid-Resistant Surgical Gowns, Fabric-Reinforced Surgical Gowns, Barrier Reusable Surgical Gowns, Lightweight Surgical Gowns, ...
GI Supply is a division of Chek Med Systems, which produces disposable medical devices. We offer products like polar wand, spot, viaduct, scopetote, garments, Hpfast/Hpone & biteblocks. Our helicobact more...
www.gi-supply.com | Send Inquiry | Phone: +1-(717)-761-1170
FDA Registration: 2529592 Quality: CE Certified
Products: Helicobacter pylori Urease Test Kits, Surgical Gowns (FDA Code: FYA), Fluid-Resistant Surgical Gowns, Fabric-Reinforced Surgical Gowns, Barrier Reusable Surgical Gowns, Lightweight Surgical Gowns, ...
GI Supply is a division of Chek Med Systems, which produces disposable medical devices. We offer products like polar wand, spot, viaduct, scopetote, garments, Hpfast/Hpone & biteblocks. Our helicobact more...
Sklar Instruments | Address: 889 S. Matlack St, West Chester, Pennsylvania 19382, USA
www.sklarcorp.com | Send Inquiry | Phone: +1-(610)-430-3200, 800-221-2166
FDA Registration: 2431166
Products: Alligator Forceps, Adult Stethoscope, Aneroid Sphygmomanometer, Aortic Aneurysm Clamps, Anastomosis Clamps, Adult Laryngoscope Lamp, ...
Sklar Instruments supplies surgical instruments. Our product categories are arthroscopy, dental, dermal, diagnostic, electrosurgery, genitourinary, and orthodontics. Our Sklar Tite™ line of seal more...
www.sklarcorp.com | Send Inquiry | Phone: +1-(610)-430-3200, 800-221-2166
FDA Registration: 2431166
Products: Alligator Forceps, Adult Stethoscope, Aneroid Sphygmomanometer, Aortic Aneurysm Clamps, Anastomosis Clamps, Adult Laryngoscope Lamp, ...
Sklar Instruments supplies surgical instruments. Our product categories are arthroscopy, dental, dermal, diagnostic, electrosurgery, genitourinary, and orthodontics. Our Sklar Tite™ line of seal more...
Smith & Nephew Inc. | Address: 1450 Brooks Road, Memphis, Tennessee 38116, USA
www.smith-nephew.com | Phone: +1-(901)-399-2121, 800-821-5700
Annual Revenues: USD 50-100 Million Employee Count: ~400 Quality: ISO 9001 Certified
Products: Middle Ear Implants, ENT Implants, Ventilation Tubes, AC-Powered Operating Room Table (FDA Code: FQO), AC-Powered Surgical Instrument Motor (FDA Code: GEY), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Abdominal Trocar, ...
Smith & Nephew is a wound care management company that manufactures and supplies medical products for the diagnosis of wound care management. Our products & services for wound, skin, IV, & burn care i more...
www.smith-nephew.com | Phone: +1-(901)-399-2121, 800-821-5700
Annual Revenues: USD 50-100 Million Employee Count: ~400 Quality: ISO 9001 Certified
Products: Middle Ear Implants, ENT Implants, Ventilation Tubes, AC-Powered Operating Room Table (FDA Code: FQO), AC-Powered Surgical Instrument Motor (FDA Code: GEY), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Abdominal Trocar, ...
Smith & Nephew is a wound care management company that manufactures and supplies medical products for the diagnosis of wound care management. Our products & services for wound, skin, IV, & burn care i more...
DeRoyal Industries | Address: 200 DeBusk Lane, Powell, Tennessee 37849, USA
www.deroyal.com | Send Inquiry | Phone: +1-(800)-251-9864
FDA Registration: 1048770 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Splints, Autoclaves, Procedure Trays, Retractors, Esophageal Stethoscopes (FDA Code: BZW), Aspirators, ...
DeRoyal Industries manufactures healthcare products. Our product ranges from orthopedic hospital brands to online tools that power the medical industry. Our night splint is available with adjustable s more...
www.deroyal.com | Send Inquiry | Phone: +1-(800)-251-9864
FDA Registration: 1048770 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Splints, Autoclaves, Procedure Trays, Retractors, Esophageal Stethoscopes (FDA Code: BZW), Aspirators, ...
DeRoyal Industries manufactures healthcare products. Our product ranges from orthopedic hospital brands to online tools that power the medical industry. Our night splint is available with adjustable s more...
Utah Medical Products, Inc. | Address: 7043 South 300 West, Midvale, Utah 84047-1048, USA
www.utahmed.com | Send Inquiry | Phone: +1-(800)-533-4984,801-566-1200
FDA Registration: 1718873 Year Established: 1978 Annual Revenues: USD 25-50 Million Employee Count: ~220 Quality: ISO 9000, ISO 9001, CE Certified
Products: Generators, Blood Pressure Monitors, Drainage Catheter, Surgical Smoke Evacuation System, Electrosurgical Pens, Pressure Transducer Tester, ...
Utah Medical Products Inc manufactures & markets a broad range of disposable and reusable specialty medical devices. Our products include arterial blood collection, blood pressure monitoring accessori more...
www.utahmed.com | Send Inquiry | Phone: +1-(800)-533-4984,801-566-1200
FDA Registration: 1718873 Year Established: 1978 Annual Revenues: USD 25-50 Million Employee Count: ~220 Quality: ISO 9000, ISO 9001, CE Certified
Products: Generators, Blood Pressure Monitors, Drainage Catheter, Surgical Smoke Evacuation System, Electrosurgical Pens, Pressure Transducer Tester, ...
Utah Medical Products Inc manufactures & markets a broad range of disposable and reusable specialty medical devices. Our products include arterial blood collection, blood pressure monitoring accessori more...
Merit Medical Systems, Inc. | Address: 1600 West Merit Parkway, South Jordan, Utah 84095, USA
www.merit.com | Send Inquiry | Phone: +1-(801)-253-1600
FDA Registration: 1721504 Year Established: 1987 Annual Revenues: USD 100-500 Million Employee Count: ~1700 Quality: ISO 9001, CE Certified
Products: Cardiology Surgery Instruments, Guide Catheters, Inflation Devices, Angioplasty Accessories, Pericardiocentesis Drainage Catheters, Diagnostic Guide Wires, ...
Merit Medical Systems, Inc. manufactures medical devices used in diagnostic and interventional cardiology & radiology procedures. Our primary products are inflation devices, diagnostic and therapeutic more...
www.merit.com | Send Inquiry | Phone: +1-(801)-253-1600
FDA Registration: 1721504 Year Established: 1987 Annual Revenues: USD 100-500 Million Employee Count: ~1700 Quality: ISO 9001, CE Certified
Products: Cardiology Surgery Instruments, Guide Catheters, Inflation Devices, Angioplasty Accessories, Pericardiocentesis Drainage Catheters, Diagnostic Guide Wires, ...
Merit Medical Systems, Inc. manufactures medical devices used in diagnostic and interventional cardiology & radiology procedures. Our primary products are inflation devices, diagnostic and therapeutic more...
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FDA Code / Regulation: KDD / 878.4800
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9.
