Surgical Instrument Tray Suppliers
Limit companies to: Worldwide USA
Safer Sleep LLC | Address: 3322 West End Avenue, Suite 705, Nashville, Tennessee 37203, USA 
www.safersleep.com | Send Inquiry | Phone: +1-(615)-577-2300
Products: Prefilled Syringe Safety Needle, Surgical Instrument Tray (FDA Code: FSM), Anesthesia Gas-Machine (FDA Code: BSZ), Surgical Needle Tray (FDA Code: FSH), Bar Code Label, Automated Anesthetic Patient Record Systems, ...
Safer Sleep LLC provides anesthesia safety & record automation solution for hospitals and ambulatory surgical facilities. Our SAFERsleep® System replaces the handwritten record and reduces anaesth more...
www.safersleep.com | Send Inquiry | Phone: +1-(615)-577-2300
Products: Prefilled Syringe Safety Needle, Surgical Instrument Tray (FDA Code: FSM), Anesthesia Gas-Machine (FDA Code: BSZ), Surgical Needle Tray (FDA Code: FSH), Bar Code Label, Automated Anesthetic Patient Record Systems, ...
Safer Sleep LLC provides anesthesia safety & record automation solution for hospitals and ambulatory surgical facilities. Our SAFERsleep® System replaces the handwritten record and reduces anaesth more...
Kentron Health Care, Inc. | Address: 3604 Kelton Jackson Rd., Springfield, Tennessee 37172, USA
www.kentronmedical.com | Send Inquiry | Phone: +1-(866)-385-0573
FDA Registration: 1062671
Products: Oxygen Masks (FDA Code: BYG), Stethoscopes, Splints, Forceps (FDA Code: HTD), Finger Splints, Esophageal Stethoscopes (FDA Code: BZW), ...
Kentron Health Care, Inc. is a manufacturer of surgical and medical instruments. Our product line includes sterile and non sterile latex gloves, vinyl & polyethylene gloves, hospital plastics, nursing more...
www.kentronmedical.com | Send Inquiry | Phone: +1-(866)-385-0573
FDA Registration: 1062671
Products: Oxygen Masks (FDA Code: BYG), Stethoscopes, Splints, Forceps (FDA Code: HTD), Finger Splints, Esophageal Stethoscopes (FDA Code: BZW), ...
Kentron Health Care, Inc. is a manufacturer of surgical and medical instruments. Our product line includes sterile and non sterile latex gloves, vinyl & polyethylene gloves, hospital plastics, nursing more...
Arthrocare Corporation | Address: 7500 Rialto Boulevard, Building Two, Suite 100, Austin, Texas 78735, USA
www.arthrocare.com | Send Inquiry | Phone: +1-(512)-391-3900
FDA Registration: 3012358417 Year Established: 1993 Annual Revenues: < USD 1 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Drills, Vertebroplasty, Bone Cement (FDA Code: LOD), Delivery Systems, Ear & Hearing Protection, Goggles & Protective Eyewear, ...
Arthrocare Corporation designs surgical instruments that improve patient outcomes by using our internationally patented Coblation® technology. Our technology precisely dissolves target tissue and more...
www.arthrocare.com | Send Inquiry | Phone: +1-(512)-391-3900
FDA Registration: 3012358417 Year Established: 1993 Annual Revenues: < USD 1 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Drills, Vertebroplasty, Bone Cement (FDA Code: LOD), Delivery Systems, Ear & Hearing Protection, Goggles & Protective Eyewear, ...
Arthrocare Corporation designs surgical instruments that improve patient outcomes by using our internationally patented Coblation® technology. Our technology precisely dissolves target tissue and more...
Spine Smith L.P. | Address: 93 Red River, Austin, Texas 78701, USA
Send Inquiry | Phone: +1-(512)-206-0770
FDA Registration: 3006404071
Products: Surgical Retractor Systems (FDA Code: GAD), Drill Bit (FDA Code: HTW), Bone Taps (FDA Code: HWX), Tamps (FDA Code: HXG), Surgical Retractor (FDA Code: GAD), Surgical Instrument Tray (FDA Code: FSM), ...
Spine Smith L.P. designs, develops and markets implants & biologics for surgical fixation, correction & tissue regeneration of the spine. Our product area includes medical devices, regenerative biolog more...
Send Inquiry | Phone: +1-(512)-206-0770
FDA Registration: 3006404071
Products: Surgical Retractor Systems (FDA Code: GAD), Drill Bit (FDA Code: HTW), Bone Taps (FDA Code: HWX), Tamps (FDA Code: HXG), Surgical Retractor (FDA Code: GAD), Surgical Instrument Tray (FDA Code: FSM), ...
Spine Smith L.P. designs, develops and markets implants & biologics for surgical fixation, correction & tissue regeneration of the spine. Our product area includes medical devices, regenerative biolog more...
Encore Medical, L.P. | Address: 9800 Metric Blvd., Austin, Texas 78758, USA
www.djosurgical.com | Phone: +1-(512)-832-9500, 800-456-8696
FDA Registration: 1644408
Products: Drill Bit (FDA Code: HTW), Nail Extractors (FDA Code: HWB), Rib Rongeurs (FDA Code: HTX), Surgical Instrument Tray (FDA Code: FSM), General & Plastic Saw Surgical Blade (FDA Code: GFA), Instrument Surgical Guide (FDA Code: FZX), ...
Encore Medical, L.P. is a designer, manufacturer and distributor of orthopedic surgery products. Our Reverse® shoulder prosthesis is indicated for use in patients with a functional deltoid muscle, more...
www.djosurgical.com | Phone: +1-(512)-832-9500, 800-456-8696
FDA Registration: 1644408
Products: Drill Bit (FDA Code: HTW), Nail Extractors (FDA Code: HWB), Rib Rongeurs (FDA Code: HTX), Surgical Instrument Tray (FDA Code: FSM), General & Plastic Saw Surgical Blade (FDA Code: GFA), Instrument Surgical Guide (FDA Code: FZX), ...
Encore Medical, L.P. is a designer, manufacturer and distributor of orthopedic surgery products. Our Reverse® shoulder prosthesis is indicated for use in patients with a functional deltoid muscle, more...
NovoSci | Address: 2021 Airport Road, Conroe, Texas 77301, USA
www.novosci.us | Send Inquiry | Phone: +1-(281)-363-4949, 800-854-0567
FDA Registration: 1625519 Year Established: 2003 Annual Revenues: USD 50-100 Million Employee Count: ~20 Quality: ISO 13485:2003, ISO 11135 Certified
Products: Tubing, Surgical Drapes & Packs (FDA Code: KKX), Vascular Clamps (FDA Code: DXC), Surgical Drapes (FDA Code: KKX), Oxygen Filters, General Tubing, ...
NovoSci develops, manufactures and distributes innovative medical devices that enable the cardiologists, surgeons & perfusionists to treat cardiovascular disease. Our product categories are disposable more...
www.novosci.us | Send Inquiry | Phone: +1-(281)-363-4949, 800-854-0567
FDA Registration: 1625519 Year Established: 2003 Annual Revenues: USD 50-100 Million Employee Count: ~20 Quality: ISO 13485:2003, ISO 11135 Certified
Products: Tubing, Surgical Drapes & Packs (FDA Code: KKX), Vascular Clamps (FDA Code: DXC), Surgical Drapes (FDA Code: KKX), Oxygen Filters, General Tubing, ...
NovoSci develops, manufactures and distributes innovative medical devices that enable the cardiologists, surgeons & perfusionists to treat cardiovascular disease. Our product categories are disposable more...
Wexler Surgical | Address: 11333 Chimney Rock Road, Suite #120, Houston, Texas 77035, USA
www.wexlersurgical.com | Send Inquiry | Phone: +1-(713)-723-6900, 800-414-1076
FDA Registration: 1646747 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: CE Certified
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Trays (FDA Code: LRP), ...
Wexler Surgical offers the specialty surgical instrumentation in titanium and stainless steel for ophthalmic surgery. Our wide range of products include forceps, needle holders, scissors, retractors, more...
www.wexlersurgical.com | Send Inquiry | Phone: +1-(713)-723-6900, 800-414-1076
FDA Registration: 1646747 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: CE Certified
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Trays (FDA Code: LRP), ...
Wexler Surgical offers the specialty surgical instrumentation in titanium and stainless steel for ophthalmic surgery. Our wide range of products include forceps, needle holders, scissors, retractors, more...
Hallmark Sales Corporation | Address: 1601 Peachleaf, Houston, Texas 77039, USA
Phone: +1-(281)-590-1367
Year Established: 1978 Annual Revenues: USD 1-5 Million Employee Count: ~80
Products: Suture Removal Kit (FDA Code: MCZ), First Aid Kit Boxes, OSHA Compliant, First Aid Kits, Ophthalmology, Surgical Instrument Trays, First Aid Kits, Burn Care First Aid Kits, ...
Hallmark Sales Corporation deals with first aid kits. more...
Phone: +1-(281)-590-1367
Year Established: 1978 Annual Revenues: USD 1-5 Million Employee Count: ~80
Products: Suture Removal Kit (FDA Code: MCZ), First Aid Kit Boxes, OSHA Compliant, First Aid Kits, Ophthalmology, Surgical Instrument Trays, First Aid Kits, Burn Care First Aid Kits, ...
Hallmark Sales Corporation deals with first aid kits. more...
Metasurg | Address: 16350 Park Ten Place Suite 101, Houston, Texas 77084, USA
www.metasurg.com | Send Inquiry | Phone: +1-(866)-433-5656
Products: Forceps (FDA Code: HTD), Titanium Internal fixation Systems, Drill Bit (FDA Code: HTW), Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Bone Clamp (FDA Code: HXD), ...
Metasurg specializes in the production of orthopedic implant systems. Our product line comprises of Ti6 titanium internal fixation system, Ti6 digital fusion system, and the biomotion first MPJ cannul more...
www.metasurg.com | Send Inquiry | Phone: +1-(866)-433-5656
Products: Forceps (FDA Code: HTD), Titanium Internal fixation Systems, Drill Bit (FDA Code: HTW), Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Bone Clamp (FDA Code: HXD), ...
Metasurg specializes in the production of orthopedic implant systems. Our product line comprises of Ti6 titanium internal fixation system, Ti6 digital fusion system, and the biomotion first MPJ cannul more...
Tedan Surgical Innovations, LLc | Address: 11333, Chimney Rock Road, Suite 180, Houston, Texas 77035, USA
www.tedansurgical.com | Send Inquiry | Phone: +1-(713)-726-0886/877-726-0886
FDA Registration: 3005726885
Products: Forceps (FDA Code: HTD), Retractors, Self-Retaining Retractors (FDA Code: FFO), Surgical Trays (FDA Code: LRP), Surgical Retractor Systems (FDA Code: GAD), Small Depth Gauge (FDA Code: HTJ), ...
Tedan Surgical Innovations, LLc offers cervical products, lumbar products and distraction screws. Our distraction screw has a bullet shaped head, long self-tapping flute and a sharp tip, which provide more...
www.tedansurgical.com | Send Inquiry | Phone: +1-(713)-726-0886/877-726-0886
FDA Registration: 3005726885
Products: Forceps (FDA Code: HTD), Retractors, Self-Retaining Retractors (FDA Code: FFO), Surgical Trays (FDA Code: LRP), Surgical Retractor Systems (FDA Code: GAD), Small Depth Gauge (FDA Code: HTJ), ...
Tedan Surgical Innovations, LLc offers cervical products, lumbar products and distraction screws. Our distraction screw has a bullet shaped head, long self-tapping flute and a sharp tip, which provide more...
Medical Techniques USA | Address: 125 North 400 West, Suite C, North Salt Lake, Utah 84054, USA
www.medicaltechniquesusa.com | Send Inquiry | Phone: +1-(801)-936-4501
FDA Registration: 1721368 Year Established: 1980 Annual Revenues: USD 1-5 Million Quality: ISO 13485, CE Certified
Products: Guidewires, Catheter Introducers (FDA Code: DYB), Gowns, Surgical Drapes & Packs (FDA Code: KKX), Surgical Drapes (FDA Code: KKX), Disposable Procedure Kit, ...
Medical Techniques USA provides cardiology, radiology, angiography, and surgical products. Our products are designed to diagnostic and interventional catheterization needs. We manufacture disposable p more...
www.medicaltechniquesusa.com | Send Inquiry | Phone: +1-(801)-936-4501
FDA Registration: 1721368 Year Established: 1980 Annual Revenues: USD 1-5 Million Quality: ISO 13485, CE Certified
Products: Guidewires, Catheter Introducers (FDA Code: DYB), Gowns, Surgical Drapes & Packs (FDA Code: KKX), Surgical Drapes (FDA Code: KKX), Disposable Procedure Kit, ...
Medical Techniques USA provides cardiology, radiology, angiography, and surgical products. Our products are designed to diagnostic and interventional catheterization needs. We manufacture disposable p more...
Gynex Corporation | Address: 2789 - 152nd Avenue Ne, Redmond, Washington 98052, USA
www.gynex.com | Send Inquiry | Phone: +1-(425)-882-1179, 800-220-5988
FDA Registration: 3032109
Products: Colposcopes, Vaginal Retractors (FDA Code: HDL), Clamps, Forceps (FDA Code: HTD), Scissors, Tubing, ...
Gynex Corporation specializes in providing OB/GYN instruments and equipment to customers worldwide. We offer anesthetic, biopsy punches, clamps, cleaning supplies, colposcopes, curettes, dilators, fet more...
www.gynex.com | Send Inquiry | Phone: +1-(425)-882-1179, 800-220-5988
FDA Registration: 3032109
Products: Colposcopes, Vaginal Retractors (FDA Code: HDL), Clamps, Forceps (FDA Code: HTD), Scissors, Tubing, ...
Gynex Corporation specializes in providing OB/GYN instruments and equipment to customers worldwide. We offer anesthetic, biopsy punches, clamps, cleaning supplies, colposcopes, curettes, dilators, fet more...
Instrumed, Inc. | Address: 19495 144th Ave NE #B-210, Woodinville, Washington 98072, USA
www.instrumedinc.com | Send Inquiry | Phone: +1-(425)-486 4340
FDA Registration: 1811755
Products: Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Bone Cement Removal Devices, Arthroscopes (FDA Code: HRX), Bone Cement (FDA Code: LOD), Bone Cement Mixing Systems, ...
Instrumed, Inc. develops and markets medical devices used during orthopedic surgery of the arms & legs. We manufacture orthopedic surgical equipment, urological stents, urological surgical catheters, more...
www.instrumedinc.com | Send Inquiry | Phone: +1-(425)-486 4340
FDA Registration: 1811755
Products: Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Bone Cement Removal Devices, Arthroscopes (FDA Code: HRX), Bone Cement (FDA Code: LOD), Bone Cement Mixing Systems, ...
Instrumed, Inc. develops and markets medical devices used during orthopedic surgery of the arms & legs. We manufacture orthopedic surgical equipment, urological stents, urological surgical catheters, more...
Polar Ware Company | Address: 502 Highway 67, Kiel, Wisconsin 53083-3943, USA
www.polarware.com | Send Inquiry | Phone: +1-(920)-894.2490, 800.237.3655
FDA Registration: 2183714 Year Established: 1907 Annual Revenues: USD 1-5 Million Employee Count: ~250
Products: Instrument Stands, General Medical Supplies, General Surgical Instruments, General Surgery Supplies, Plasticware, Trays, ...
Polar Ware Company offers surgical products. Our patient care products include a complete line of reusable stainless steel patient products. We also deal with a wide selection of color identifiable pl more...
www.polarware.com | Send Inquiry | Phone: +1-(920)-894.2490, 800.237.3655
FDA Registration: 2183714 Year Established: 1907 Annual Revenues: USD 1-5 Million Employee Count: ~250
Products: Instrument Stands, General Medical Supplies, General Surgical Instruments, General Surgery Supplies, Plasticware, Trays, ...
Polar Ware Company offers surgical products. Our patient care products include a complete line of reusable stainless steel patient products. We also deal with a wide selection of color identifiable pl more...
Placon Corporation | Address: 6096 McKee Road, Madison, Wisconsin 53719-5114, USA
www.placon.com | Send Inquiry | Phone: +1-(608)-271-5634, 800-541-1535
Year Established: 1966 Annual Revenues: USD 50-100 Million Employee Count: ~300 Quality: ISO 14001 Certified
Products: Sterilization Containers, Surgical Instrument Tray (FDA Code: FSM), Plastic Foam, Medical Device Trays, Implant Trays, Transfer Trays, ...
Placon specializes in thermoformed packaging of food, consumer packaged retail and medical device. Our product area includes consumer packaging, food packaging, stock packaging, medical packaging and more...
www.placon.com | Send Inquiry | Phone: +1-(608)-271-5634, 800-541-1535
Year Established: 1966 Annual Revenues: USD 50-100 Million Employee Count: ~300 Quality: ISO 14001 Certified
Products: Sterilization Containers, Surgical Instrument Tray (FDA Code: FSM), Plastic Foam, Medical Device Trays, Implant Trays, Transfer Trays, ...
Placon specializes in thermoformed packaging of food, consumer packaged retail and medical device. Our product area includes consumer packaging, food packaging, stock packaging, medical packaging and more...
Tyco Healthcare UK Ltd. | Address: Fareham Rd., Gosport, Hants, United Kingdom 
www.tycohealthcare.co.uk | Send Inquiry | Phone: +44-(1329)-224114
Products: Non-Absorbable Sutures (FDA Code: GAO), Surgical Staplers, Circular Staplers, Surgical Staplers, Titanium Staples, Surgical Staplers, Stainless Steel Staples, Surgical Retractor Systems (FDA Code: GAD), Ophthalmology, Surgical Instrument Trays, ...
Tyco Healthcare UK Ltd. is a manufacturer and distributor of medical devices. Our products include disposable medical supplies, monitoring equipment, medical instruments and bulk analgesic pharmaceuti more...
www.tycohealthcare.co.uk | Send Inquiry | Phone: +44-(1329)-224114
Products: Non-Absorbable Sutures (FDA Code: GAO), Surgical Staplers, Circular Staplers, Surgical Staplers, Titanium Staples, Surgical Staplers, Stainless Steel Staples, Surgical Retractor Systems (FDA Code: GAD), Ophthalmology, Surgical Instrument Trays, ...
Tyco Healthcare UK Ltd. is a manufacturer and distributor of medical devices. Our products include disposable medical supplies, monitoring equipment, medical instruments and bulk analgesic pharmaceuti more...
Howmedica International Ltd | Address: 622 Western Avenue, Park Royal, London W3 0TF, United Kingdom
Phone: +44-(181)-992-8044
Employee Count: ~150 Quality: ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Bone Drills, Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Ankle Arthroscopy Drill Guides, ...
Howmedica International Ltd specializes in offering orthopedic products. Our products include bone fixation plate, bone drills, femoral prosthetic implants, foot prosthesis, human bone rasps, nail ext more...
Phone: +44-(181)-992-8044
Employee Count: ~150 Quality: ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Bone Drills, Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Ankle Arthroscopy Drill Guides, ...
Howmedica International Ltd specializes in offering orthopedic products. Our products include bone fixation plate, bone drills, femoral prosthetic implants, foot prosthesis, human bone rasps, nail ext more...
Gyrus Group PLC | Address: Fortran Road, St Mellons, Cardiff CF3 0LT, United Kingdom
Send Inquiry | Phone: +44-(0)-1189-219700
Products: Resectoscopes (FDA Code: FJL), Resection Electrodes, Endoscopic Resection Supplies, Resection Electrodes, Commercial Resection Electrodes, Coaguloop Resection Electrodes, Standard Resection Electrodes, ...
Gyrus Group PLC is a medical technology company, which focuses on the management of tissue using less traumatic techniques during open and endoscopic surgical procedures. Our products are helpful in g more...
Send Inquiry | Phone: +44-(0)-1189-219700
Products: Resectoscopes (FDA Code: FJL), Resection Electrodes, Endoscopic Resection Supplies, Resection Electrodes, Commercial Resection Electrodes, Coaguloop Resection Electrodes, Standard Resection Electrodes, ...
Gyrus Group PLC is a medical technology company, which focuses on the management of tissue using less traumatic techniques during open and endoscopic surgical procedures. Our products are helpful in g more...
Duckworth & Kent Ltd. | Address: Terence House,7 Marquis Business Centre,Royston Road,Baldock, Herts, England SG7 6XL, United Kingdom
www.duckworth-and-kent.com | Send Inquiry | Phone: +44-(1462)-893254
FDA Registration: 8021817 Employee Count: ~50 Quality: ISO 9001, CE Certified
Products: Curettes, Trephines, Chalazion Curettes, Crackers, Choppers, Calipers, Gauges, and Rulers, ...
Duckworth & Kent specializes in titanium ophthalmic surgical instrumentation. We are an ISO certified company. Our products include cannulas, capsule polisher, curettes, debriders, dilators, dissector more...
www.duckworth-and-kent.com | Send Inquiry | Phone: +44-(1462)-893254
FDA Registration: 8021817 Employee Count: ~50 Quality: ISO 9001, CE Certified
Products: Curettes, Trephines, Chalazion Curettes, Crackers, Choppers, Calipers, Gauges, and Rulers, ...
Duckworth & Kent specializes in titanium ophthalmic surgical instrumentation. We are an ISO certified company. Our products include cannulas, capsule polisher, curettes, debriders, dilators, dissector more...
Horizon Healthcare UK | Address: Marlborough House, 159 High Street, Harrow, Middlesex HA3 5DX, United Kingdom
www.horizonhealthcareuk.com | Send Inquiry | Phone: +44-(020)-8248 3724
Products: Instrument Trays, Bipolar Forceps, Monopolar Electrode Cables, Bipolar Electrode Cables, BiPolar Bayonet Forceps, Forceps, Monopolar, ...
Horizon Healthcare UK is a supplier of surgical instruments and medical equipment. Our perforated silicone mats are produced using medical grade silicone rubber. Our endoscope baskets are fitted with more...
www.horizonhealthcareuk.com | Send Inquiry | Phone: +44-(020)-8248 3724
Products: Instrument Trays, Bipolar Forceps, Monopolar Electrode Cables, Bipolar Electrode Cables, BiPolar Bayonet Forceps, Forceps, Monopolar, ...
Horizon Healthcare UK is a supplier of surgical instruments and medical equipment. Our perforated silicone mats are produced using medical grade silicone rubber. Our endoscope baskets are fitted with more...
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FDA Code / Regulation: FSM / 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.
