General Surgical Manual Instrument Suppliers
Limit companies to: Worldwide USA
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...
Accurate Surgical & Scientific Instruments Corporation | Address: 300 Shames Drive, Westbury, New York 11590, USA
www.accuratesurgical.com | Send Inquiry | Phone: +1-(516)-333-5270
FDA Registration: 2434839
Products: Microinstruments, Stevens Tenotomy Scissors, General Surgical Instruments, Single Use Surgical Instruments, Neurology Instruments, Surgical Instrument (Miscellaneous Medical), ...
Accurate Surgical & Scientific Instruments Corporation specializes in surgical instruments for microsurgery, hand, plastic, reconstructive, ophthalmology, neurosurgery, urology & infertility, ENT and more...
www.accuratesurgical.com | Send Inquiry | Phone: +1-(516)-333-5270
FDA Registration: 2434839
Products: Microinstruments, Stevens Tenotomy Scissors, General Surgical Instruments, Single Use Surgical Instruments, Neurology Instruments, Surgical Instrument (Miscellaneous Medical), ...
Accurate Surgical & Scientific Instruments Corporation specializes in surgical instruments for microsurgery, hand, plastic, reconstructive, ophthalmology, neurosurgery, urology & infertility, ENT and 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...
Ethicon Endo-Surgery, Inc. | Address: 4545 Creek Road, Cincinnati, Ohio 45242-2839, USA
www.ethiconendo.com | Send Inquiry | Phone: +1-(513)-337-8901, (800)-873-3636
FDA Registration: 3005075853 Annual Revenues: USD 1-5 Million Employee Count: ~3000 Quality: CE Certified
Products: Clamps, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Procedure Trays, Retractors, Powered Surgical Laser Instrument (FDA Code: GEX), ...
Ethicon Endo-Surgery, Inc. produces & markets advanced medical devices for minimally invasive and open surgical procedures. We offer products like brest care products, surgical stapling products, ener more...
www.ethiconendo.com | Send Inquiry | Phone: +1-(513)-337-8901, (800)-873-3636
FDA Registration: 3005075853 Annual Revenues: USD 1-5 Million Employee Count: ~3000 Quality: CE Certified
Products: Clamps, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Procedure Trays, Retractors, Powered Surgical Laser Instrument (FDA Code: GEX), ...
Ethicon Endo-Surgery, Inc. produces & markets advanced medical devices for minimally invasive and open surgical procedures. We offer products like brest care products, surgical stapling products, ener more...
Cardinal Health, Inc. | Address: 7000 Cardinal Place, Dublin, Ohio 43017, USA
www.cardinal.com | Phone: +1-(614)-757-5000, 800-234-8701
Products: Heat or Cold Packs, General Bandages, Infusion Pumps, Ambulatory Pumps, IV Infusion Systems, Surgical Drapes (FDA Code: KKX), Electronic Thermometer, ...
Cardinal Health is a manufacturer and distributor of medical & surgical supplies. Our clinical and medical products segment manufactures medication infusion & dispensing products, respiratory equipmen more...
www.cardinal.com | Phone: +1-(614)-757-5000, 800-234-8701
Products: Heat or Cold Packs, General Bandages, Infusion Pumps, Ambulatory Pumps, IV Infusion Systems, Surgical Drapes (FDA Code: KKX), Electronic Thermometer, ...
Cardinal Health is a manufacturer and distributor of medical & surgical supplies. Our clinical and medical products segment manufactures medication infusion & dispensing products, respiratory equipmen more...
Cook Vascular Incorporated | Address: P.O. Box 529, Pennsylvania 15656, USA
Send Inquiry | Phone: +1-(800)-245-4715, 724- 845-8621
FDA Registration: 2522007
Products: Lead Extraction Devices, Single Chamber Systems, Dual Chamber Systems, Peripheral Systems, Doppler Flow Devices, Dual Chamber Systems Silicone, ...
Cook Vascular Incorporated provides interventional, therapeutic and diagnostic vascular products. We also manufacture a complete line of Vital-port® vascular access ports and a wide variety of cat more...
Send Inquiry | Phone: +1-(800)-245-4715, 724- 845-8621
FDA Registration: 2522007
Products: Lead Extraction Devices, Single Chamber Systems, Dual Chamber Systems, Peripheral Systems, Doppler Flow Devices, Dual Chamber Systems Silicone, ...
Cook Vascular Incorporated provides interventional, therapeutic and diagnostic vascular products. We also manufacture a complete line of Vital-port® vascular access ports and a wide variety of cat 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...
Millennium Surgical Corp. | Address: 822 Montgomery Ave, #205, Narberth, Pennsylvania 19072, USA
www.surgicalinstruments.com | Send Inquiry | Phone: +1-(610)-771.0850
FDA Registration: 3004215117
Products: Autoclaves, Automatic Autoclaves, Adjustable Mastoid Retractor, Arteriotomy Clamp, Aspirators And Accessories, Anterior Cervical Fusion Longitudinal Retractor, ...
Millennium Surgical Corp. deals with surgical instruments of all specialties. Our product range comprises of instrument trays, eye surgical instruments, eye needles & cannulas, diamond knives, eye dra more...
www.surgicalinstruments.com | Send Inquiry | Phone: +1-(610)-771.0850
FDA Registration: 3004215117
Products: Autoclaves, Automatic Autoclaves, Adjustable Mastoid Retractor, Arteriotomy Clamp, Aspirators And Accessories, Anterior Cervical Fusion Longitudinal Retractor, ...
Millennium Surgical Corp. deals with surgical instruments of all specialties. Our product range comprises of instrument trays, eye surgical instruments, eye needles & cannulas, diamond knives, eye dra more...
Superior Surgical | Address: 176 Clover Lane, Perkiomenville, Pennsylvania 18074, USA
www.superior-surgical.com | Send Inquiry | Phone: +1-(877)-669-7646
FDA Registration: 3008017452
Products: Ophthalmic Solutions, Disposable Ophthalmic Cannulae, Ophthalmic Needles, Ophthalmic Surgery Knives, Ophthalmic Surgical Drapes, Ophthalmic Surgical Sponges, ...
Superior Surgical offers surgical products to hospitals and physicians. We also specialize in ophthalmic disposables and surgical instruments/power equipment repair. We offer eye surgical instruments, more...
www.superior-surgical.com | Send Inquiry | Phone: +1-(877)-669-7646
FDA Registration: 3008017452
Products: Ophthalmic Solutions, Disposable Ophthalmic Cannulae, Ophthalmic Needles, Ophthalmic Surgery Knives, Ophthalmic Surgical Drapes, Ophthalmic Surgical Sponges, ...
Superior Surgical offers surgical products to hospitals and physicians. We also specialize in ophthalmic disposables and surgical instruments/power equipment repair. We offer eye surgical instruments, more...
Wright Medical Technology, Inc. | Address: 5677 Airline Road, Arlington, Tennessee 38002, USA
www.wmt.com | Send Inquiry | Phone: +1-(901)-867-9971, 800-238-7117
FDA Registration: 3012429289 Year Established: 1950 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO 9002, ISO 9003, CE Certified
Products: Tibial Inserts, Patellar Implants, Metal and Ceramic Liners, All Poly Liners, Femoral Components, Total Shoulder Systems, ...
Wright Medical Technology, Inc. is a global orthopaedic medical device company. Our Advance® Uni-Knee renders normal motion and leads to a longer implant life that delays or prevents the need for more...
www.wmt.com | Send Inquiry | Phone: +1-(901)-867-9971, 800-238-7117
FDA Registration: 3012429289 Year Established: 1950 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO 9002, ISO 9003, CE Certified
Products: Tibial Inserts, Patellar Implants, Metal and Ceramic Liners, All Poly Liners, Femoral Components, Total Shoulder Systems, ...
Wright Medical Technology, Inc. is a global orthopaedic medical device company. Our Advance® Uni-Knee renders normal motion and leads to a longer implant life that delays or prevents the need for 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...
Eagle Vision | Address: 8500 Wolf Lake Drive, Suite 110, P.O. Box 34877, Memphis, Tennessee 38133, USA
www.eaglevis.com | Send Inquiry | Phone: +1-(901)-380-7000
FDA Registration: 1034718 Year Established: 1983 Employee Count: ~30 Quality: ISO, CE Certified
Products: Punctum Plugs (Punctal Plugs), Collagen Glaucoma Drainage Device, DCR Intubation Stent, Monocanalicular Stent, ColorBarT Schirmer Tear Test, Eye Moisture Panels, ...
Eagle Vision produces silicone punctum plugs, which contain patented Tapered Shaft™ and pivoting wide-flex nose for super retention. We offer products like glaucoma drainage devices, punctum plu more...
www.eaglevis.com | Send Inquiry | Phone: +1-(901)-380-7000
FDA Registration: 1034718 Year Established: 1983 Employee Count: ~30 Quality: ISO, CE Certified
Products: Punctum Plugs (Punctal Plugs), Collagen Glaucoma Drainage Device, DCR Intubation Stent, Monocanalicular Stent, ColorBarT Schirmer Tear Test, Eye Moisture Panels, ...
Eagle Vision produces silicone punctum plugs, which contain patented Tapered Shaft™ and pivoting wide-flex nose for super retention. We offer products like glaucoma drainage devices, punctum plu more...
Hartland Supplies | Address: , Nashville, Tennessee, USA
hartlandhomemedicalsupply.com | Send Inquiry
Products: General Surgical Instruments, Instruments surgical, Common Surgical Instrument, Lighted Surgical Instruments, General Surgical Manual Instrument (FDA Code: MDM), Manual Surgical Instrument, ...
Hartland Supplies specializes in providing surgical and medical instruments. Our products include walking canes, wheel chairs, thermometers, blood pressure monitors, pulse checkers, and gloves. more...
hartlandhomemedicalsupply.com | Send Inquiry
Products: General Surgical Instruments, Instruments surgical, Common Surgical Instrument, Lighted Surgical Instruments, General Surgical Manual Instrument (FDA Code: MDM), Manual Surgical Instrument, ...
Hartland Supplies specializes in providing surgical and medical instruments. Our products include walking canes, wheel chairs, thermometers, blood pressure monitors, pulse checkers, and gloves. 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...
Osteomed Corp | Address: 3885 Arapaho Road, Addison, Texas 75001, USA
www.osteomedcorp.com | Send Inquiry | Phone: +1-(972)-677-4600
FDA Registration: 2027754 Year Established: 2002 Annual Revenues: USD 25-50 Million Employee Count: ~180 Quality: ISO Certified
Products: MP Joint Implants, Hammertoe Implants, Foot Fragment Sets, Mini Lag Screw Systems, Cannulated Screw System, Cannulated Screw Fracture Fixation System, ...
Osteomed Corp is a global manufacturer and marketer of specialty medical devices, surgical implants and powered surgical instruments. We provide the surgeon with innovative products and state of the a more...
www.osteomedcorp.com | Send Inquiry | Phone: +1-(972)-677-4600
FDA Registration: 2027754 Year Established: 2002 Annual Revenues: USD 25-50 Million Employee Count: ~180 Quality: ISO Certified
Products: MP Joint Implants, Hammertoe Implants, Foot Fragment Sets, Mini Lag Screw Systems, Cannulated Screw System, Cannulated Screw Fracture Fixation System, ...
Osteomed Corp is a global manufacturer and marketer of specialty medical devices, surgical implants and powered surgical instruments. We provide the surgeon with innovative products and state of the a more...
Microsurgery Instruments, Inc. | Address: P.O. BOX 1378, Bellaire, Texas 77402, USA
www.microsurgeryusa.com | Send Inquiry | Phone: +1-(713)-664-4707
FDA Registration: 1645452
Products: Surgical Loupes, Light Sources Advanced Light Source, Light Sources White Light Source, Light Sources Creative Light Source, Light Sources Alternative Light Source, Surgical Lighting, ...
Microsurgery Instruments, Inc. specializes in microsurgery and other delicate surgical products. We focus on orthopedics, cardiovascular, plastic surgery, hand surgery, urology, surgical loupes, needl more...
www.microsurgeryusa.com | Send Inquiry | Phone: +1-(713)-664-4707
FDA Registration: 1645452
Products: Surgical Loupes, Light Sources Advanced Light Source, Light Sources White Light Source, Light Sources Creative Light Source, Light Sources Alternative Light Source, Surgical Lighting, ...
Microsurgery Instruments, Inc. specializes in microsurgery and other delicate surgical products. We focus on orthopedics, cardiovascular, plastic surgery, hand surgery, urology, surgical loupes, needl more...
Orthofix Inc. | Address: 1720 Bray Central Drive, McKinney, Texas 75069, USA
www.orthofix.com | Send Inquiry | Phone: +1-(469)-742-2500, 800-535-4492
FDA Registration: 2183449 Year Established: 1980 Employee Count: ~200 Quality: ISO Certified
Products: Proximal Femoral & Recon Nails, Spinal Orthoses, Bone Screws, Compression Distraction, Clicker, Counter Nuts, Threaded Bars, ...
Orthofix Inc. designs, manufactures & distributes medical equipment, mainly for the orthopedic market. Our orthopedics, spine and sports medicine divisions offer innovative treatment options for adult more...
www.orthofix.com | Send Inquiry | Phone: +1-(469)-742-2500, 800-535-4492
FDA Registration: 2183449 Year Established: 1980 Employee Count: ~200 Quality: ISO Certified
Products: Proximal Femoral & Recon Nails, Spinal Orthoses, Bone Screws, Compression Distraction, Clicker, Counter Nuts, Threaded Bars, ...
Orthofix Inc. designs, manufactures & distributes medical equipment, mainly for the orthopedic market. Our orthopedics, spine and sports medicine divisions offer innovative treatment options for adult more...
Instratek Incorporated | Address: 210 Springhill Drive #130, Spring, Texas 77386, USA
www.instratek.com | Send Inquiry | Phone: +1-(281)-890-8020
FDA Registration: 1645311 Year Established: 1993 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: ISO 9001, CE Certified
Products: Endoscopic Carpal Tunnel Release Systems, Single-portal Endoscopic Carpal Tunnel Release, Bilateral Carpal Tunnel Syndrome, Endoscopic Gastrocnemius Recession System, Endoscopic Trigger Finger Release System, Cannulated Titanium Bone Screw System, ...
Instratek Incorporated develops & markets instrumentation for a variety of endoscopic procedures. We offer products such as arthroereisis systemT, endoscopic carpal tunnel releaseT, endoscopic trigger more...
www.instratek.com | Send Inquiry | Phone: +1-(281)-890-8020
FDA Registration: 1645311 Year Established: 1993 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: ISO 9001, CE Certified
Products: Endoscopic Carpal Tunnel Release Systems, Single-portal Endoscopic Carpal Tunnel Release, Bilateral Carpal Tunnel Syndrome, Endoscopic Gastrocnemius Recession System, Endoscopic Trigger Finger Release System, Cannulated Titanium Bone Screw System, ...
Instratek Incorporated develops & markets instrumentation for a variety of endoscopic procedures. We offer products such as arthroereisis systemT, endoscopic carpal tunnel releaseT, endoscopic trigger 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: MDM / 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.
