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, Suction Canister Systems, Pleural Catheters for Blunt Dissection, Drainage Line Set, Double-Valved Ascites Shunt, Single-Valved Ascites Shunt, ...
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, Suction Canister Systems, Pleural Catheters for Blunt Dissection, Drainage Line Set, Double-Valved Ascites Shunt, Single-Valved Ascites Shunt, ...
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: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Retractors, Scissors, Sutures, Needles, ...
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: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Retractors, Scissors, Sutures, Needles, ...
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: Procedure Trays, Needles, Catheter Introducers (FDA Code: DYB), Prostate Biopsy Needles, Syringe/Needle Combos, Biopsy Instruments (FDA Code: KNW), ...
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: Procedure Trays, Needles, Catheter Introducers (FDA Code: DYB), Prostate Biopsy Needles, Syringe/Needle Combos, Biopsy Instruments (FDA Code: KNW), ...
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: Oxygen Masks (FDA Code: BYG), Fetal Monitors, Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Hematology Analyzers, ...
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: Oxygen Masks (FDA Code: BYG), Fetal Monitors, Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Hematology Analyzers, ...
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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, Needles, Guidewires, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, Needles, Guidewires, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
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: Hysteroscopic Equipment, Powered Surgical Laser Instrument (FDA Code: GEX), Biopsy Forceps, Cytology Brushes, Grasping Forceps, Urethral Catheters (FDA Code: GBM), ...
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: Hysteroscopic Equipment, Powered Surgical Laser Instrument (FDA Code: GEX), Biopsy Forceps, Cytology Brushes, Grasping Forceps, Urethral Catheters (FDA Code: GBM), ...
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: Hypodermic Needles, Catheter Stylets (FDA Code: DRB), Thrombectomy Devices, Infusion Catheter, Infusion Catheter (FDA Code: JCY), Reusable Hypodermic Needles, Stainless Steel Brain Biopsy Needles, ...
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: Hypodermic Needles, Catheter Stylets (FDA Code: DRB), Thrombectomy Devices, Infusion Catheter, Infusion Catheter (FDA Code: JCY), Reusable Hypodermic Needles, Stainless Steel Brain Biopsy Needles, ...
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: Skin Grafting Instruments, Hernia Repair Grafts, Arthritis Treatments, Miscellaneous Injectables, Vitamins & Minerals (Pediatric/Adult), Surgical Mesh, Hernia Repair Grafts, ...
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: Skin Grafting Instruments, Hernia Repair Grafts, Arthritis Treatments, Miscellaneous Injectables, Vitamins & Minerals (Pediatric/Adult), Surgical Mesh, Hernia Repair Grafts, ...
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, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Scissors, Tissue Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
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, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Scissors, Tissue Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
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: Femuroral Intramedullary Nails, Bone Taps (FDA Code: HWX), Orthopaedic Trauma & Clinical Therapies, Wire Cutters (FDA Code: HXZ), Bone Mill (FDA Code: LYS), Fibula Plates, ...
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: Femuroral Intramedullary Nails, Bone Taps (FDA Code: HWX), Orthopaedic Trauma & Clinical Therapies, Wire Cutters (FDA Code: HXZ), Bone Mill (FDA Code: LYS), Fibula Plates, ...
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: Umbilical Tapes, Forceps (FDA Code: HTD), Scissors, Sutures, Surgicel, Dissectors, ...
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: Umbilical Tapes, Forceps (FDA Code: HTD), Scissors, Sutures, Surgicel, Dissectors, ...
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: Autoclaves, Surgical Marking Pens (FDA Code: HRP), Sterilizing Aids, Diagnostic Aids, Analgesics, Antibiotics & Antibacterials, ...
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: Autoclaves, Surgical Marking Pens (FDA Code: HRP), Sterilizing Aids, Diagnostic Aids, Analgesics, Antibiotics & Antibacterials, ...
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, Patient Examination Gowns and Capes (FDA Code: FME), Biopsy Instruments (FDA Code: KNW), Airways & Bite Blocks, Oral Airways, Airways & Bite Blocks, Bite Guards and Blocks, ...
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, Patient Examination Gowns and Capes (FDA Code: FME), Biopsy Instruments (FDA Code: KNW), Airways & Bite Blocks, Oral Airways, Airways & Bite Blocks, Bite Guards and Blocks, ...
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: Blood Pressure Measuring Equipment, Pelvimeters, Clamps, Curettes, Elevators, Forceps (FDA Code: HTD), ...
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: Blood Pressure Measuring Equipment, Pelvimeters, Clamps, Curettes, Elevators, Forceps (FDA Code: HTD), ...
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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Fixation Forceps, Tissue Forceps, Kremer Fixation Forceps, Double Prong Skin Hooks, ...
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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Fixation Forceps, Tissue Forceps, Kremer Fixation Forceps, Double Prong Skin Hooks, ...
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, Forceps (FDA Code: HTD), Procedure Trays, Retractors, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
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, Forceps (FDA Code: HTD), Procedure Trays, Retractors, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
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, Electrode Cables (FDA Code: IKD), Urethral Catheters (FDA Code: GBM), Blood Pressure Monitors, Drainage Catheter, Umbilical Artery Catheter (FDA Code: FOS), ...
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, Electrode Cables (FDA Code: IKD), Urethral Catheters (FDA Code: GBM), Blood Pressure Monitors, Drainage Catheter, Umbilical Artery Catheter (FDA Code: FOS), ...
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, Scalpels, Tubing, Needles, Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, ...
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, Scalpels, Tubing, Needles, Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, ...
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.
