Surgical Trays Suppliers
Limit companies to: Worldwide USA
Sontec Instruments, Inc. | Address: 7248 South Tucson Way, Colorado 80112, USA 
www.sontecinstruments.com | Send Inquiry | Phone: +1-(303)-790-9411
FDA Registration: 1720747 Employee Count: ~20
Products: Curettes, Manipulators, Rotators, Spatulas and Picks, Lacrimal Dilators and Cannulas, Fixation Rings, Vannas Capsulotomy Scissors, Intraocular Lens Manipulators, ...
Sontec Instruments, Inc. supplies surgical instrumentation to the medical industry. We deliver a complete line of surgical instruments for cardiovascular/thoracic, urological, gynecological/obstetrica more...
www.sontecinstruments.com | Send Inquiry | Phone: +1-(303)-790-9411
FDA Registration: 1720747 Employee Count: ~20
Products: Curettes, Manipulators, Rotators, Spatulas and Picks, Lacrimal Dilators and Cannulas, Fixation Rings, Vannas Capsulotomy Scissors, Intraocular Lens Manipulators, ...
Sontec Instruments, Inc. supplies surgical instrumentation to the medical industry. We deliver a complete line of surgical instruments for cardiovascular/thoracic, urological, gynecological/obstetrica 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...
Anspach Effort, Inc. | Address: 4500 Riverside Drive, Palm Beach Gardens, Florida 33410, USA
www.anspach.com | Send Inquiry | Phone: +1-(561)-627-1080,800-327-6887
FDA Registration: 1045834
Products: Pneumatic Neurosurgical Drill Systems, Electric Neurosurgical Drill Systems, Tens Electric Heating Pads, Electrical Equipment For Laboratory, Electric Massagers, Thermophore Electric Moist Heating Pad, ...
Anspach Effort, Inc. manufactures high-speed instrumentation for neurosurgery, neurotology, otology & orthopaedics. Our XMax high performance system provides a perfect pneumatic system to handle a com more...
www.anspach.com | Send Inquiry | Phone: +1-(561)-627-1080,800-327-6887
FDA Registration: 1045834
Products: Pneumatic Neurosurgical Drill Systems, Electric Neurosurgical Drill Systems, Tens Electric Heating Pads, Electrical Equipment For Laboratory, Electric Massagers, Thermophore Electric Moist Heating Pad, ...
Anspach Effort, Inc. manufactures high-speed instrumentation for neurosurgery, neurotology, otology & orthopaedics. Our XMax high performance system provides a perfect pneumatic system to handle a com more...
Marina Medical Instruments Inc. | Address: 955 Shotgun Rd, Sunrise, Florida 33326, USA
www.marinamedical.com | Send Inquiry | Phone: +1-(954)-924-4418, 800-697-1119
FDA Registration: 2084346 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Curettes, Hemostatic Mosquito Forceps, Adson Tissue Forceps, Jewelers Bipolar Forceps, Jaeger Lid Plates, Bone Curettes, ...
Marina Medical Instruments Inc. supplies medical instruments. Our product range comprises of vaginal agenesis, fan retractors, pelvic surgery, surgical caps, scopes, electrosurgical, cystoscopy & bari more...
www.marinamedical.com | Send Inquiry | Phone: +1-(954)-924-4418, 800-697-1119
FDA Registration: 2084346 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Curettes, Hemostatic Mosquito Forceps, Adson Tissue Forceps, Jewelers Bipolar Forceps, Jaeger Lid Plates, Bone Curettes, ...
Marina Medical Instruments Inc. supplies medical instruments. Our product range comprises of vaginal agenesis, fan retractors, pelvic surgery, surgical caps, scopes, electrosurgical, cystoscopy & bari more...
Stradis Healthcare, LLC | Address: 805 Marathon Pkwy, Lawrenceville, Georgia 30045, USA
www.stradismed.com | Send Inquiry | Phone: +1-(770)-962-2425, (800)-886-7257
FDA Registration: 1055754
Products: Blades, Medical Blades, Dissecting Blades, Endosurgical Blades, Disposable Blades, Sterilized Blades, ...
Stradis Healthcare, LLC is a global provider and manufacturer, specializing in custom surgical procedure packs & disposable surgical supplies. We also supply a wide variety of contract packaging servi more...
www.stradismed.com | Send Inquiry | Phone: +1-(770)-962-2425, (800)-886-7257
FDA Registration: 1055754
Products: Blades, Medical Blades, Dissecting Blades, Endosurgical Blades, Disposable Blades, Sterilized Blades, ...
Stradis Healthcare, LLC is a global provider and manufacturer, specializing in custom surgical procedure packs & disposable surgical supplies. We also supply a wide variety of contract packaging servi more...
Micrins, Inc. | Address: 28438 Ballard Drive, Lake Forest, Illinois 60045, USA
www.micrins.com | Send Inquiry | Phone: +1-(847)-549-1410
Year Established: 1987
Products: Elevators, Dressing Forceps, Dissectors, Backhaus Towel Forceps, Dilators, Endoscopic Facelift Elevator, ...
Micrins, Inc. provides surgical instruments and equipment for plastic, micro & hand surgery. We offer a complete line of aesthetic and reconstructive surgical instrumentation. We offer products such a more...
www.micrins.com | Send Inquiry | Phone: +1-(847)-549-1410
Year Established: 1987
Products: Elevators, Dressing Forceps, Dissectors, Backhaus Towel Forceps, Dilators, Endoscopic Facelift Elevator, ...
Micrins, Inc. provides surgical instruments and equipment for plastic, micro & hand surgery. We offer a complete line of aesthetic and reconstructive surgical instrumentation. We offer products such a more...
Vyaire Medical, Inc. | Address: 26125 North Riverwoods Blvd, Mettawa, Illinois 60045, USA
www.vyaire.com | Send Inquiry | Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001 Annual Revenues: USD 50-100 Million Employee Count: ~230 Quality: ISO 9001, CE Certified
Products: Speech & Testing Equipment, Impedance Testing Systems, Audiometers & Accessories, Evoked Response Testing Systems, Infant Screening & Testing Units, Otoacoustic Emission Test Equipment, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l more...
www.vyaire.com | Send Inquiry | Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001 Annual Revenues: USD 50-100 Million Employee Count: ~230 Quality: ISO 9001, CE Certified
Products: Speech & Testing Equipment, Impedance Testing Systems, Audiometers & Accessories, Evoked Response Testing Systems, Infant Screening & Testing Units, Otoacoustic Emission Test Equipment, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l more...
Cook Urological | Address: 1100 West Morgan Street,P.O. Box 227, Spencer, Indiana 47460, USA
www.cookurological.com | Phone: +1-(812)-829-4891
FDA Registration: 1825146
Products: Airway Management, ET Tubes, Airway Management, Adult Bronchoscope, Airway Management, Fiber Bronchoscope, Airway Management, Pediatric Bronchoscope, Airway Management, 3 Or Three Way Foley Catheter, ...
Cook Urological provides professionals in urological health care with medical products, employing the minimally invasive diagnostic and therapeutic device technologies, already proven clinically in ca more...
www.cookurological.com | Phone: +1-(812)-829-4891
FDA Registration: 1825146
Products: Airway Management, ET Tubes, Airway Management, Adult Bronchoscope, Airway Management, Fiber Bronchoscope, Airway Management, Pediatric Bronchoscope, Airway Management, 3 Or Three Way Foley Catheter, ...
Cook Urological provides professionals in urological health care with medical products, employing the minimally invasive diagnostic and therapeutic device technologies, already proven clinically in ca more...
Hologic Inc | Address: 35 Crosby Drive, Bedford, Massachusetts 01730, USA
www.hologic.com | Send Inquiry | Phone: +1-(781)-999-7300
FDA Registration: 1220984 Year Established: 1985
Products: Contract Manufacturers, Needles, Fluoroscopy Systems, Fluoroscopic Imaging Systems, Portable Fluoroscopes, Digital Mammography Systems, ...
Hologic Inc develops, manufactures and supplies premium diagnostic & medical imaging systems dedicated to serve the healthcare needs of women. We produce digital imaging technology for general radiogr more...
www.hologic.com | Send Inquiry | Phone: +1-(781)-999-7300
FDA Registration: 1220984 Year Established: 1985
Products: Contract Manufacturers, Needles, Fluoroscopy Systems, Fluoroscopic Imaging Systems, Portable Fluoroscopes, Digital Mammography Systems, ...
Hologic Inc develops, manufactures and supplies premium diagnostic & medical imaging systems dedicated to serve the healthcare needs of women. We produce digital imaging technology for general radiogr more...
Zirc Company | Address: 3918 Highway 55 S.E., Buffalo, Minnesota 55313, USA
www.zirc.com | Send Inquiry | Phone: +1-(763)-682-6636, 800-328-3899
FDA Registration: 2126387 Year Established: 1967 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: ISO 9001, CE Certified
Products: Sterilizing Aids, Infect Waste & Linen Disposal, General Medical Supplies, Surgical Sterilizing Aids, Surgical Trays (FDA Code: LRP), Surgical Trays (FDA Code: LRP), ...
Zirc Company supplies color coded, sterilizable, plastic dental products. We are an ISO certified company. Our illuminator mouth mirror is a rhodium mirror, which has a ridged handle for better grip a more...
www.zirc.com | Send Inquiry | Phone: +1-(763)-682-6636, 800-328-3899
FDA Registration: 2126387 Year Established: 1967 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: ISO 9001, CE Certified
Products: Sterilizing Aids, Infect Waste & Linen Disposal, General Medical Supplies, Surgical Sterilizing Aids, Surgical Trays (FDA Code: LRP), Surgical Trays (FDA Code: LRP), ...
Zirc Company supplies color coded, sterilizable, plastic dental products. We are an ISO certified company. Our illuminator mouth mirror is a rhodium mirror, which has a ridged handle for better grip a more...
PMT Corporation | Address: 1500 Park Road, Chanhassen, Minnesota 55317, USA
www.pmtcorp.com | Send Inquiry | Phone: +1-(952)-470-0866, 800-626-5463
FDA Registration: 2182979 Year Established: 1979 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 13485, CE Certified
Products: Bipolar Electrode Cables, Adapters & Connectors, Neonatal Temperature Probe Adapter, Back Orthoses, Adult Skin Temperature Probes, Adult Rectal Temperature Probes, Battery-Operated Operating Headlamp (FDA Code: HPP), ...
PMT Corporation manufactures products for neurosurgery, orthopaedics, plastic, and reconstructive surgery. We are accredited with ISO 13485: 2003 certification. All our products are FDA approved. Our more...
www.pmtcorp.com | Send Inquiry | Phone: +1-(952)-470-0866, 800-626-5463
FDA Registration: 2182979 Year Established: 1979 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 13485, CE Certified
Products: Bipolar Electrode Cables, Adapters & Connectors, Neonatal Temperature Probe Adapter, Back Orthoses, Adult Skin Temperature Probes, Adult Rectal Temperature Probes, Battery-Operated Operating Headlamp (FDA Code: HPP), ...
PMT Corporation manufactures products for neurosurgery, orthopaedics, plastic, and reconstructive surgery. We are accredited with ISO 13485: 2003 certification. All our products are FDA approved. Our more...
Osteotech, Inc. | Address: 51 James Way, Eatontown, New Jersey 07724, USA
www.osteotech.com | Send Inquiry | Phone: +1-(732)-542-2800
FDA Registration: 2249915 Year Established: 1986 Annual Revenues: USD 50-100 Million Employee Count: ~360
Products: Demineralized Bone Matrix, Allografts, Human Demineralized Bone Matrix, Osteoinductive Demineralized Bone Matrix, Soft Tissue Allografts, Bone Allografts, ...
Osteotech, Inc. specializes in the processing of human bone & connective tissue for transplantation and create, assemble & distribute biologic, biomaterial & device systems for musculoskeletal surgery more...
www.osteotech.com | Send Inquiry | Phone: +1-(732)-542-2800
FDA Registration: 2249915 Year Established: 1986 Annual Revenues: USD 50-100 Million Employee Count: ~360
Products: Demineralized Bone Matrix, Allografts, Human Demineralized Bone Matrix, Osteoinductive Demineralized Bone Matrix, Soft Tissue Allografts, Bone Allografts, ...
Osteotech, Inc. specializes in the processing of human bone & connective tissue for transplantation and create, assemble & distribute biologic, biomaterial & device systems for musculoskeletal surgery more...
Ethicon, Inc. | Address: P.O. Box 151,Route 22 West, Somerville, New Jersey 08876, USA
www.ethicon.com | Send Inquiry | Phone: +1-(800)-888-9234
FDA Registration: 3003702646 Employee Count: ~9000
Products: Absorbable Suture Anchors, Absorbable Surgical Sutures, Absorbable Hemostats Surgicel, 80° Vertical Microscissors, Absorbable Adhesion Barrier (FDA Code: MCN), Absorbable Laparoscopy Suture, ...
Ethicon, Inc. is a global medical device company, which specializes in surgical sutures. Our product portfolio comprises of aesthetic medicine, biosurgicals, hernia solutions, infection control, pelvi more...
www.ethicon.com | Send Inquiry | Phone: +1-(800)-888-9234
FDA Registration: 3003702646 Employee Count: ~9000
Products: Absorbable Suture Anchors, Absorbable Surgical Sutures, Absorbable Hemostats Surgicel, 80° Vertical Microscissors, Absorbable Adhesion Barrier (FDA Code: MCN), Absorbable Laparoscopy Suture, ...
Ethicon, Inc. is a global medical device company, which specializes in surgical sutures. Our product portfolio comprises of aesthetic medicine, biosurgicals, hernia solutions, infection control, pelvi more...
E-Z-EM Inc. | Address: 1111 Marcus Avenue Suite LL26, Lake Success, New York 11042, USA
www.ezem.com | Send Inquiry | Phone: +1-(516)-333-8230
FDA Registration: 2411512 Year Established: 1962
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), X-Ray Aids, Diagnostic Aids, Biopsy Supplies, Contrast Media, Disposable Needles, ...
E-Z-EM Inc manufactures products used for imaging the gastrointestinal tract. Our product ranges from a disposable barium enema administration kit to advanced CT and virtual colonoscopy products. Our more...
www.ezem.com | Send Inquiry | Phone: +1-(516)-333-8230
FDA Registration: 2411512 Year Established: 1962
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), X-Ray Aids, Diagnostic Aids, Biopsy Supplies, Contrast Media, Disposable Needles, ...
E-Z-EM Inc manufactures products used for imaging the gastrointestinal tract. Our product ranges from a disposable barium enema administration kit to advanced CT and virtual colonoscopy products. Our 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...
Conmed Integrated Systems | Address: 1815 NW 169th Place, Suite 4020, Beaverton, Oregon 97006, USA
www.conmed.com/IntegratedSystems_newdesign.php | Send Inquiry | Phone: +1-(503)-614-1106
Products: Integrated OR Systems, Arthroscopy Instruments, Electrosurgery, Endoscopy Devices, Patient Care Suction Apparatus (FDA Code: DWM), Integrated Diagnostic Systems, ...
Conmed Integrated Systems provides technology and service for the medical environment. We design completely integrated surgical suites and other patient critical care environments. We offer products l more...
www.conmed.com/IntegratedSystems_newdesign.php | Send Inquiry | Phone: +1-(503)-614-1106
Products: Integrated OR Systems, Arthroscopy Instruments, Electrosurgery, Endoscopy Devices, Patient Care Suction Apparatus (FDA Code: DWM), Integrated Diagnostic Systems, ...
Conmed Integrated Systems provides technology and service for the medical environment. We design completely integrated surgical suites and other patient critical care environments. We offer products l more...
B. Braun Medical Inc. | Address: 824 Twelfth Avenue, Bethlehem, Pennsylvania 18018-3524, USA
www.bbraunusa.com | Send Inquiry | Phone: +1-(610)-691-5400
FDA Registration: 2523676 Year Established: 1979 Annual Revenues: USD 10-25 Million Employee Count: ~600 Quality: ISO 9000, CE Certified
Products: Procedure Trays, Caps, Disposable Needles, IV Catheters & Infusion Sets, IV Sets, General Medical Supplies, ...
B. Braun Medical Inc. offers medical products. Our product categories are admixture products, dialysis products, infusion pump systems & sets, urology sets & solutions, pain control products and vascu more...
www.bbraunusa.com | Send Inquiry | Phone: +1-(610)-691-5400
FDA Registration: 2523676 Year Established: 1979 Annual Revenues: USD 10-25 Million Employee Count: ~600 Quality: ISO 9000, CE Certified
Products: Procedure Trays, Caps, Disposable Needles, IV Catheters & Infusion Sets, IV Sets, General Medical Supplies, ...
B. Braun Medical Inc. offers medical products. Our product categories are admixture products, dialysis products, infusion pump systems & sets, urology sets & solutions, pain control products and vascu 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...
Small Bone Innovations, Inc | Address: 1380 S. Pennsylvania Avenue, Morrisville, Pennsylvania 19067, USA
www.totalsmallbone.com | Phone: +1-(215)-428-1791
Products: CMC and IP Joint Implants, Biaxial Total Wrist Arthroplasty, Carpal Fusion Plate, Dorsal Distal Radius Plate, Elbow Implant, Proximal Radial Head Prosthesis, Elbow Implant, Recon Prosthesis, ...
Small Bone Innovations, Inc. delivers arthroplasty, fixation, trauma and biologic solutions. Our Head™ proximal radial head is designed to anatomically articulate with the convexity of the capit more...
www.totalsmallbone.com | Phone: +1-(215)-428-1791
Products: CMC and IP Joint Implants, Biaxial Total Wrist Arthroplasty, Carpal Fusion Plate, Dorsal Distal Radius Plate, Elbow Implant, Proximal Radial Head Prosthesis, Elbow Implant, Recon Prosthesis, ...
Small Bone Innovations, Inc. delivers arthroplasty, fixation, trauma and biologic solutions. Our Head™ proximal radial head is designed to anatomically articulate with the convexity of the capit more...
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FDA Code / Regulation: LRP / 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.
