One-Piece Scalpel Suppliers
Limit companies to: Worldwide USA
Oasis Medical, Inc. | Address: 510-528 S. Vermont Ave., Glendora, California 91741, USA 
www.oasismedical.com | Send Inquiry | Phone: +1-(909)-305-5400
FDA Registration: 2083373 Year Established: 1987 Annual Revenues: USD 10-25 Million Employee Count: ~60 Quality: ISO 9001, CE Certified
Products: Lacrimal Dilators and Cannulas, MVR Blades, Punctum Plugs (Punctal Plugs), Absorbing Supplies, Stab Blades, Tunnel Knives, ...
Oasis Medical, Inc. manufactures and markets eye care products for ophthalmic & optometric professionals. We offer products such as cataract, dry eye, refractive, retinal & accessories. Our own tradem more...
www.oasismedical.com | Send Inquiry | Phone: +1-(909)-305-5400
FDA Registration: 2083373 Year Established: 1987 Annual Revenues: USD 10-25 Million Employee Count: ~60 Quality: ISO 9001, CE Certified
Products: Lacrimal Dilators and Cannulas, MVR Blades, Punctum Plugs (Punctal Plugs), Absorbing Supplies, Stab Blades, Tunnel Knives, ...
Oasis Medical, Inc. manufactures and markets eye care products for ophthalmic & optometric professionals. We offer products such as cataract, dry eye, refractive, retinal & accessories. Our own tradem more...
Hospital Marketing Services Co., Inc. | Address: PO Box 1217, 162 Great Hill Road, Naugatuck, Connecticut 06770-1217, USA
www.hmsmedical.com | Send Inquiry | Phone: +1-(800)-786-5094
Employee Count: ~50 Quality: CE Certified
Products: Heat or Cold Packs, Scalpels, Surgical Blades, Surgical Scalpels, Suture Needles, Disposable Scalpels, ...
Hospital Marketing Services Co., Inc. is a source for instant thermal products for hot & cold therapies, as well as skin markers, suture needles, scalpels, surgical blades, thermal binders and abdomin more...
www.hmsmedical.com | Send Inquiry | Phone: +1-(800)-786-5094
Employee Count: ~50 Quality: CE Certified
Products: Heat or Cold Packs, Scalpels, Surgical Blades, Surgical Scalpels, Suture Needles, Disposable Scalpels, ...
Hospital Marketing Services Co., Inc. is a source for instant thermal products for hot & cold therapies, as well as skin markers, suture needles, scalpels, surgical blades, thermal binders and abdomin 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...
Medtronic Xomed Surgical Products, Inc | Address: 6743 Southpoint Drive North, Jacksonville, Florida 32216-0980, USA
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Sinus Trochars and Cannulae, Surgical Navigation Interface/Display, Nerve Stimulators, Eyeshields, General Diagnostic Supplies, General Surgical Aids, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Sinus Trochars and Cannulae, Surgical Navigation Interface/Display, Nerve Stimulators, Eyeshields, General Diagnostic Supplies, General Surgical Aids, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I 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...
DePuy Orthopaedics, Inc | Address: 700 Orthopaedic Drive, Warsaw, Indiana 46582, USA
www.depuy.com | Send Inquiry | Phone: +1-(574)-267-8143, 800-473-3789
Year Established: 1895 Employee Count: ~600
Products: Bone Cement (FDA Code: LOD), Orthopedics, Compression Hip Screw, Free Lock Compression Hip Screws, FRS-Fusion and Reconstruction System, Acetabular Cup System, Mobile-Bearing Knee System, ...
DePuy, Inc., provides healthcare solutions in orthopaedics, spinal care, pain management, and central nervous system. Our orthopaedic devices and supplies include hip, knee, extremity, trauma, cement more...
www.depuy.com | Send Inquiry | Phone: +1-(574)-267-8143, 800-473-3789
Year Established: 1895 Employee Count: ~600
Products: Bone Cement (FDA Code: LOD), Orthopedics, Compression Hip Screw, Free Lock Compression Hip Screws, FRS-Fusion and Reconstruction System, Acetabular Cup System, Mobile-Bearing Knee System, ...
DePuy, Inc., provides healthcare solutions in orthopaedics, spinal care, pain management, and central nervous system. Our orthopaedic devices and supplies include hip, knee, extremity, trauma, cement more...
Luxtec | Address: 99 Hartwell Street, West Boylston, Maryland 01583, USA
www.luxtec.com | Send Inquiry | Phone: +1-(508)-835-9700
Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Light Sources, Surgical Headlights, Recording Systems, Headlight Box / Light source, Digital Video Recorders, Recording Devices, ...
Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monito more...
www.luxtec.com | Send Inquiry | Phone: +1-(508)-835-9700
Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Light Sources, Surgical Headlights, Recording Systems, Headlight Box / Light source, Digital Video Recorders, Recording Devices, ...
Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monito more...
Cancer Diagnostics, Inc. | Address: P.O. Box 1205, Birmingham, Michigan 48012-1205, USA
www.cancerdiagnostics.com | Send Inquiry | Phone: +1-(408)-980-7392, 919-744-5564
FDA Registration: 3007496191
Products: Scalpels, Eyeshields, Disposable Surgical scalpels, Tissue Marking Dyes, Base Mold Release Agent and Sprays, Squeezable Tissue Marking Dyes, ...
Cancer Diagnostics, Inc. manufactures specialty products for the pathology laboratory. Our product list comprises of tissue marking dyes, scalpels, knives, grossing pads & rulers, cassettes, biopsy ba more...
www.cancerdiagnostics.com | Send Inquiry | Phone: +1-(408)-980-7392, 919-744-5564
FDA Registration: 3007496191
Products: Scalpels, Eyeshields, Disposable Surgical scalpels, Tissue Marking Dyes, Base Mold Release Agent and Sprays, Squeezable Tissue Marking Dyes, ...
Cancer Diagnostics, Inc. manufactures specialty products for the pathology laboratory. Our product list comprises of tissue marking dyes, scalpels, knives, grossing pads & rulers, cassettes, biopsy ba more...
Aspen Surgical Products | Address: 6945 Southbelt Dr. SE, Caledonia, Michigan 49316, USA
www.aspensurgical.com | Send Inquiry | Phone: +1-(616)-698-7100, 888-364-7004
FDA Registration: 1836161 Year Established: 1982 Annual Revenues: USD 5-10 Million Employee Count: ~70 Quality: ISO 9002, CE Certified
Products: Clamps, General Medical Supplies, General Surgical Instruments, Suture Needles, Vascular Clamps (FDA Code: DXC), Metal Skull Clamps, ...
Aspen Surgical Products deals with medical products. We are an ISO: 13485 certified and FDA-registered facility We carry an extensive line of products including operating room disposables, wound care more...
www.aspensurgical.com | Send Inquiry | Phone: +1-(616)-698-7100, 888-364-7004
FDA Registration: 1836161 Year Established: 1982 Annual Revenues: USD 5-10 Million Employee Count: ~70 Quality: ISO 9002, CE Certified
Products: Clamps, General Medical Supplies, General Surgical Instruments, Suture Needles, Vascular Clamps (FDA Code: DXC), Metal Skull Clamps, ...
Aspen Surgical Products deals with medical products. We are an ISO: 13485 certified and FDA-registered facility We carry an extensive line of products including operating room disposables, wound care more...
Becton, Dickson & Co., | Address: One Becton Drive, Franklin Lakes, New Jersey 07417, USA
www.bd.com/us | Phone: +1-(201)-847.6800
FDA Registration: 1119779 Annual Revenues: USD 10-25 Million Employee Count: ~1600 Quality: ISO 9000, CE Certified
Products: Software Programs, CCD Cameras, & Gamma Cameras, Biomedical Devices, 3D Imaging Devices, Frame Grabbers, Densitometers Accessories, ...
Becton, Dickinson & Co., manufactures and distributes a broad range of medical supplies, devices, laboratory equipment and diagnostic products. Our product BD Soluvia™ is a prefillable microinje more...
www.bd.com/us | Phone: +1-(201)-847.6800
FDA Registration: 1119779 Annual Revenues: USD 10-25 Million Employee Count: ~1600 Quality: ISO 9000, CE Certified
Products: Software Programs, CCD Cameras, & Gamma Cameras, Biomedical Devices, 3D Imaging Devices, Frame Grabbers, Densitometers Accessories, ...
Becton, Dickinson & Co., manufactures and distributes a broad range of medical supplies, devices, laboratory equipment and diagnostic products. Our product BD Soluvia™ is a prefillable microinje more...
Propper Manufacturing Co. Inc. | Address: 36-04 Skillman Avenue, Long Island City, New York 11101, USA
www.proppermfg.com | Send Inquiry | Phone: +1-(800)-832-4300
FDA Registration: 2410251 Year Established: 1935 Annual Revenues: USD 25-50 Million Employee Count: ~160 Quality: ISO 9001, CE Certified
Products: Spirometers, Autoclaves, Hematology Analyzers, Thermometers, Sterilizing Aids, Bags, Wraps & Tubing, ...
Propper Manufacturing Co. Inc. produces sterilization medical/surgical products, laboratory products, fecal occult blood test diagnostic kits and diagnostic instruments. We also serve the medical & de more...
www.proppermfg.com | Send Inquiry | Phone: +1-(800)-832-4300
FDA Registration: 2410251 Year Established: 1935 Annual Revenues: USD 25-50 Million Employee Count: ~160 Quality: ISO 9001, CE Certified
Products: Spirometers, Autoclaves, Hematology Analyzers, Thermometers, Sterilizing Aids, Bags, Wraps & Tubing, ...
Propper Manufacturing Co. Inc. produces sterilization medical/surgical products, laboratory products, fecal occult blood test diagnostic kits and diagnostic instruments. We also serve the medical & de more...
Teleflex Medical | Address: PO Box 12600, Research Triangle Park, North Carolina 27709, USA
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Absorbable Sutures (FDA Code: GAK), General Diagnostic Supplies, General Medical Supplies, General Sutures/Needles, Non-Absorbable Sutures (FDA Code: GAO), Suture Needles, ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Absorbable Sutures (FDA Code: GAK), General Diagnostic Supplies, General Medical Supplies, General Sutures/Needles, Non-Absorbable Sutures (FDA Code: GAO), Suture Needles, ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
Aesculap Inc. | Address: 3773 Corporate Parkway, Center Valley, Pennsylvania 18034, USA
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Curettes, Drills, Titanium Plating Systems, Suction Tubes, Dural Substitute, Posterior, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Curettes, Drills, Titanium Plating Systems, Suction Tubes, Dural Substitute, Posterior, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
Miltex, Inc. | Address: 589 Davies Drive, York, Pennsylvania 17402, USA
www.miltex.com | Send Inquiry | Phone: +1-(717)-840-9335
FDA Registration: 2523190 Year Established: 1950 Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Scissors, Vasectomy Ringed Forceps, Vasectomy Hemostats, General Medical Supplies, General Surgical Instruments, ...
Miltex, Inc. specializes in surgical and dental instruments. Our product line includes surgical, dental, gynecology, animal health, podiatry and repair instruments. Our Miltex® endometrial samplin more...
www.miltex.com | Send Inquiry | Phone: +1-(717)-840-9335
FDA Registration: 2523190 Year Established: 1950 Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Scissors, Vasectomy Ringed Forceps, Vasectomy Hemostats, General Medical Supplies, General Surgical Instruments, ...
Miltex, Inc. specializes in surgical and dental instruments. Our product line includes surgical, dental, gynecology, animal health, podiatry and repair instruments. Our Miltex® endometrial samplin more...
Surgistar Inc. | Address: 820 Corridor Park Blvd, Knoxville, Tennessee 37932, USA
www.surgistar.com | Send Inquiry | Phone: +1-(865)-671-4300
FDA Registration: 2028661 Year Established: 1992 Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: ISO 9001 Certified
Products: Sickle Blades, MVR Blades, Trabeculectomy Blades, Neck Supplies, Blades and Knives, Tunnel Blades, Cannulas, ...
Surgistar, Inc. is a manufacturer of single use ophthalmic, ENT and surgical products. Our ophthalmology products include knives, blades, cannulas, microkeratome blades, tubing, and corneal trephines. more...
www.surgistar.com | Send Inquiry | Phone: +1-(865)-671-4300
FDA Registration: 2028661 Year Established: 1992 Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: ISO 9001 Certified
Products: Sickle Blades, MVR Blades, Trabeculectomy Blades, Neck Supplies, Blades and Knives, Tunnel Blades, Cannulas, ...
Surgistar, Inc. is a manufacturer of single use ophthalmic, ENT and surgical products. Our ophthalmology products include knives, blades, cannulas, microkeratome blades, tubing, and corneal trephines. 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...
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...
Sandel Medical Industries, Llc | Address: 19736 Dearborn Street, Chatsworth, California 91311, USA
www.sandelmedical.com | Send Inquiry | Phone: +1-(866)-764-3327
FDA Registration: 3004125670 Quality: ISO 13485 Certified
Products: Scalpels, Chairs & stools, Foot Stools, Scalpel Handle (FDA Code: GDZ), Safety Scalpel System, Footstool, ...
Sandel Medical Industries, Llc focuses on addressing and eliminating safety issues for patients and health care staff. Our products include engineered sharps injury prevention, ergonomic workplace saf more...
www.sandelmedical.com | Send Inquiry | Phone: +1-(866)-764-3327
FDA Registration: 3004125670 Quality: ISO 13485 Certified
Products: Scalpels, Chairs & stools, Foot Stools, Scalpel Handle (FDA Code: GDZ), Safety Scalpel System, Footstool, ...
Sandel Medical Industries, Llc focuses on addressing and eliminating safety issues for patients and health care staff. Our products include engineered sharps injury prevention, ergonomic workplace saf more...
Griff Industries, Inc. | Address: 19761 Bahama St., Northridge, California 91324, USA
www.griffindustries.com | Send Inquiry | Phone: +1-(818)-709-4743, 800-709-4743
FDA Registration: 2031528 Year Established: 1999 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001 Certified
Products: Cosmetic Surgery, Needle Holder (Serrated), Coronary Needle Holders, Blood Collection Sets with Needle Holder, Blood Needle Holder Systems, Arterial Blood Sampling Kit (FDA Code: CBT), Conductive Patient Restraint (FDA Code: BRT), ...
Griff Industries, Inc. offers a line of disposable and resposable (limited reuse) products for use in & around the operating room. We provide design, mold building and molding services along with seco more...
www.griffindustries.com | Send Inquiry | Phone: +1-(818)-709-4743, 800-709-4743
FDA Registration: 2031528 Year Established: 1999 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001 Certified
Products: Cosmetic Surgery, Needle Holder (Serrated), Coronary Needle Holders, Blood Collection Sets with Needle Holder, Blood Needle Holder Systems, Arterial Blood Sampling Kit (FDA Code: CBT), Conductive Patient Restraint (FDA Code: BRT), ...
Griff Industries, Inc. offers a line of disposable and resposable (limited reuse) products for use in & around the operating room. We provide design, mold building and molding services along with seco more...
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FDA Code / Regulation: GDX / 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.
