Ligature Carrier Set Suppliers
Limit companies to: Worldwide USA
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...
Cooper Surgical, Inc. | Address: 95 Corporate Drive, Trumbul, Connecticut 06611, USA
www.coopersurgical.com | Send Inquiry | Phone: +001-(203)-601-5200
FDA Registration: 1216677 Year Established: 1990 Annual Revenues: USD 100-500 Million Employee Count: ~430 Quality: ISO 9001, CE Certified
Products: Biopsy Punches (FDA Code: FCI), Bone Densitometer (FDA Code: KGI), Bone Densitometry System, Angled Biopsy Punch, Amniotome (FDA Code: HGE), Assisted Reproduction Devices, ...
Cooper Surgical, Inc. provides medical devices and procedure solutions that improve health care delivery to women regardless of the clinical setting. Our product categories are obstetrics, family plan more...
www.coopersurgical.com | Send Inquiry | Phone: +001-(203)-601-5200
FDA Registration: 1216677 Year Established: 1990 Annual Revenues: USD 100-500 Million Employee Count: ~430 Quality: ISO 9001, CE Certified
Products: Biopsy Punches (FDA Code: FCI), Bone Densitometer (FDA Code: KGI), Bone Densitometry System, Angled Biopsy Punch, Amniotome (FDA Code: HGE), Assisted Reproduction Devices, ...
Cooper Surgical, Inc. provides medical devices and procedure solutions that improve health care delivery to women regardless of the clinical setting. Our product categories are obstetrics, family plan 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...
KLS Martin, L.P. | Address: 11239-1 St.Johns Industrial Parkway S, Jacksonville, Florida 32246-7652, USA
www.klsmartinusa.com | Send Inquiry | Phone: +1-(904)-641-7746, 800-625-1557
FDA Registration: 1057946 Year Established: 1993 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9001 Certified
Products: Elevators, Instruments, Castroviejo Calipers, Neurological Instruments, Pituitary Scoops, Cervical Spine Retractor System, Hand Held Instruments, Periosteals Elevators, ...
KLS Martin, L.P. focuses on surgical fields. Our mario® instrument management software manages & controls sterile supplies according to economic, technical & process-oriented criteria. Our C-plate more...
www.klsmartinusa.com | Send Inquiry | Phone: +1-(904)-641-7746, 800-625-1557
FDA Registration: 1057946 Year Established: 1993 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9001 Certified
Products: Elevators, Instruments, Castroviejo Calipers, Neurological Instruments, Pituitary Scoops, Cervical Spine Retractor System, Hand Held Instruments, Periosteals Elevators, ...
KLS Martin, L.P. focuses on surgical fields. Our mario® instrument management software manages & controls sterile supplies according to economic, technical & process-oriented criteria. Our C-plate 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...
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...
Zimmer, Inc. | Address: P.O. Box 708 ,1800 West Center Street, Warsaw, Indiana 46581-0708, USA
www.zimmer.com | Phone: +1-(574)-372-4790, 800-613-6131
FDA Registration: 1822565 Year Established: 1927 Annual Revenues: > USD 1 Billion Employee Count: ~7600 Quality: ISO 9001, CE Certified
Products: Splints, Synthetic Spacers, Patellar Implants, Femoral Components, Total Shoulder Systems, Aspirators, ...
Zimmer, Inc. manufactures orthopedic products and instruments. We specialize in joint replacement solutions for knee pain & hip pain. We deliver comprehensive spine care solutions for acute and chroni more...
www.zimmer.com | Phone: +1-(574)-372-4790, 800-613-6131
FDA Registration: 1822565 Year Established: 1927 Annual Revenues: > USD 1 Billion Employee Count: ~7600 Quality: ISO 9001, CE Certified
Products: Splints, Synthetic Spacers, Patellar Implants, Femoral Components, Total Shoulder Systems, Aspirators, ...
Zimmer, Inc. manufactures orthopedic products and instruments. We specialize in joint replacement solutions for knee pain & hip pain. We deliver comprehensive spine care solutions for acute and chroni 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...
Solos Endoscopy,Inc. | Address: 65 Sprague Street, Boston, Massachusetts 02136, USA
www.solosendoscopy.com | Send Inquiry | Phone: +1-(617)-360-9700
Products: Scissors, Light Sources, Dissectors, Gastroenterologic Needle Holder (FDA Code: FHQ), Cameras, Recording Devices, ...
Solos Endoscopy develops advanced surgical instruments and diagnostic solutions. We offer products like tympanoplasty & stapes, endoscopic sinus surgery & septorhinoplasty. Our monitors and video cart more...
www.solosendoscopy.com | Send Inquiry | Phone: +1-(617)-360-9700
Products: Scissors, Light Sources, Dissectors, Gastroenterologic Needle Holder (FDA Code: FHQ), Cameras, Recording Devices, ...
Solos Endoscopy develops advanced surgical instruments and diagnostic solutions. We offer products like tympanoplasty & stapes, endoscopic sinus surgery & septorhinoplasty. Our monitors and video cart more...
Kirwan Surgical Products | Address: 180 Enterprise Drive, PO Box 427, Marshfield, Massachusetts 02050, USA
www.ksp.com | Send Inquiry | Phone: +1-(781)-834-9500, 888-KIRWANS
FDA Registration: 1219619 Year Established: 1979 Employee Count: ~180 Quality: ISO 9001, CE Certified
Products: Bipolar Forceps, Monopolar Aids, Standard, Reusable Bipolar Forceps, Microsurgical Bipolar Forceps, Titanium Bipolar Forceps (Ophthalmology), ...
Kirwan Surgical Products manufactures surgical instruments for microsurgical specialties such as neurosurgery, ophthalmology & ear, nose and throat. Our Aura™ line of non-stick forceps offers a more...
www.ksp.com | Send Inquiry | Phone: +1-(781)-834-9500, 888-KIRWANS
FDA Registration: 1219619 Year Established: 1979 Employee Count: ~180 Quality: ISO 9001, CE Certified
Products: Bipolar Forceps, Monopolar Aids, Standard, Reusable Bipolar Forceps, Microsurgical Bipolar Forceps, Titanium Bipolar Forceps (Ophthalmology), ...
Kirwan Surgical Products manufactures surgical instruments for microsurgical specialties such as neurosurgery, ophthalmology & ear, nose and throat. Our Aura™ line of non-stick forceps offers a more...
Codman & Shurtleff, Inc. | Address: 325 Paramount Dr., Raynham, Massachusetts 02767, USA
www.codman.com | Send Inquiry | Phone: +1-(508)-880-8100
FDA Registration: 1226348 Year Established: 1857 Annual Revenues: < USD 1 Million Employee Count: ~1200 Quality: ISO 9000 Certified
Products: Anterior Cervical Fusion Kit, Cervical Drill Tips, Cervical Drill Guards, Cross Bar Handle, Depth Gauge (FDA Code: HTJ), Spanner Gauge, ...
Codman & Shurtleff, Inc. develops and markets a wide range of diagnostic & therapeutic products for the treatment of central nervous system disorders. Our focus is on intractable pain management, pedi more...
www.codman.com | Send Inquiry | Phone: +1-(508)-880-8100
FDA Registration: 1226348 Year Established: 1857 Annual Revenues: < USD 1 Million Employee Count: ~1200 Quality: ISO 9000 Certified
Products: Anterior Cervical Fusion Kit, Cervical Drill Tips, Cervical Drill Guards, Cross Bar Handle, Depth Gauge (FDA Code: HTJ), Spanner Gauge, ...
Codman & Shurtleff, Inc. develops and markets a wide range of diagnostic & therapeutic products for the treatment of central nervous system disorders. Our focus is on intractable pain management, pedi 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...
Boss Instruments, Ltd. | Address: 395 Reas Ford Road, Suite 120, Earlysville, Virginia 22936, USA
www.bossinst.com | Send Inquiry | Phone: +1-(800)-210-2677
FDA Registration: 1056350 Year Established: 1990 Annual Revenues: < USD 1 Million Employee Count: ~10 Quality: ISO 9000, ISO 9002, CE Certified
Products: Tissue Forceps, Sinus Trochars and Cannulae, Tourniquets, Vascular Clamps (FDA Code: DXC), Adjustable Bone Holding Forceps, Dilators, ...
Boss Instruments, Ltd. is a surgical instrument company which concentrates on the manufacture and continual development of specialty lines of instruments include ear, nose, and throat, general surgery more...
www.bossinst.com | Send Inquiry | Phone: +1-(800)-210-2677
FDA Registration: 1056350 Year Established: 1990 Annual Revenues: < USD 1 Million Employee Count: ~10 Quality: ISO 9000, ISO 9002, CE Certified
Products: Tissue Forceps, Sinus Trochars and Cannulae, Tourniquets, Vascular Clamps (FDA Code: DXC), Adjustable Bone Holding Forceps, Dilators, ...
Boss Instruments, Ltd. is a surgical instrument company which concentrates on the manufacture and continual development of specialty lines of instruments include ear, nose, and throat, general surgery more...
AMS Innovative Center-Phoenix | Address: 23030 North 15th Avenue, Phoenix, Arizona 85027, USA
www.innovaquartz.com | Send Inquiry | Phone: +1-(623)-434-1894
Year Established: 1991 Annual Revenues: USD 1-5 Million Quality: ISO, CE Certified
Products: Blood Gas Capillary Tubes, Blood Gas Capillary Tubes Sodium Heparin, General Surgical Manual Instrument (FDA Code: MDM), Endometrial Thermal Ablation Device (FDA Code: MNB), General Manual Obstetric/Gynecologic Instrument (FDA Code: KOH), Bone Fixation Screw (FDA Code: HWC), ...
AMS Innovative Center-Phoenix offers medical products and equipments. more...
www.innovaquartz.com | Send Inquiry | Phone: +1-(623)-434-1894
Year Established: 1991 Annual Revenues: USD 1-5 Million Quality: ISO, CE Certified
Products: Blood Gas Capillary Tubes, Blood Gas Capillary Tubes Sodium Heparin, General Surgical Manual Instrument (FDA Code: MDM), Endometrial Thermal Ablation Device (FDA Code: MNB), General Manual Obstetric/Gynecologic Instrument (FDA Code: KOH), Bone Fixation Screw (FDA Code: HWC), ...
AMS Innovative Center-Phoenix offers medical products and equipments. more...
Biomet Microfixation | Address: 1520 Tradeport Dr., Jacksonville, Florida 32218-2480, USA
www.biometmicrofixation.com | Send Inquiry | Phone: +1-(904)-741-4400, 800-874-7711
FDA Registration: 1032347 Year Established: 1965
Products: Basic Plastic Surgery Tray, Blepharoplasty Tray, Craniofacial Surgery Tray, Biopsy Trays, Bone Graft Replacement, Angle Blade Plate Instrument, ...
Biomet Microfixation manufactures a complete range of craniomaxillofacial products. We offer products for neurosurgical, plastic, oral & maxillofacial, craniofacial, pediatric, ENT and cardiothoracic more...
www.biometmicrofixation.com | Send Inquiry | Phone: +1-(904)-741-4400, 800-874-7711
FDA Registration: 1032347 Year Established: 1965
Products: Basic Plastic Surgery Tray, Blepharoplasty Tray, Craniofacial Surgery Tray, Biopsy Trays, Bone Graft Replacement, Angle Blade Plate Instrument, ...
Biomet Microfixation manufactures a complete range of craniomaxillofacial products. We offer products for neurosurgical, plastic, oral & maxillofacial, craniofacial, pediatric, ENT and cardiothoracic more...
Hu-Friedy | Address: 3232 N.Rockwell, Chicago, Illinois 60618-5982, USA
www.hu-friedy.com | Send Inquiry | Phone: +001-(800)-483-7433
FDA Registration: 1416605 Year Established: 1908 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9002, CE Certified
Products: Adson-Graefe Tissue Forceps, Adson 1 x 2 Teeth Tissue Forceps, Absorbable Hemostats Surgicel, 80° Vertical Microscissors, Adjustable Bone Holding Forceps, Adson Needle Holder, ...
Hu-Friedy offers a wide range of periodontal, restorative, diagnostic, surgery and orthodontic instruments. We specialize in manufacturing quality handheld dental instruments. We develop the next gene more...
www.hu-friedy.com | Send Inquiry | Phone: +001-(800)-483-7433
FDA Registration: 1416605 Year Established: 1908 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9002, CE Certified
Products: Adson-Graefe Tissue Forceps, Adson 1 x 2 Teeth Tissue Forceps, Absorbable Hemostats Surgicel, 80° Vertical Microscissors, Adjustable Bone Holding Forceps, Adson Needle Holder, ...
Hu-Friedy offers a wide range of periodontal, restorative, diagnostic, surgery and orthodontic instruments. We specialize in manufacturing quality handheld dental instruments. We develop the next gene more...
Instrumed International, Inc. | Address: 626 Cooper Court, Schaumburg, Illinois 60173, USA
www.instrumedinc.biz | Phone: +1-(847)-908-0292
FDA Registration: 1421101
Products: Laparoscopic Equipment, Retractor System, General Surgical Instruments, Titanium Microsurgical Instruments, Orthopedic Instruments, Maxillofacial Prosthesis, ...
Instrumed International, Inc. specializes in providing reusable surgical instruments. We offer surgical products for bipolar, CV/thoracic, ENT, general, hand & micro surgery, laparoscopic, laryngeal, more...
www.instrumedinc.biz | Phone: +1-(847)-908-0292
FDA Registration: 1421101
Products: Laparoscopic Equipment, Retractor System, General Surgical Instruments, Titanium Microsurgical Instruments, Orthopedic Instruments, Maxillofacial Prosthesis, ...
Instrumed International, Inc. specializes in providing reusable surgical instruments. We offer surgical products for bipolar, CV/thoracic, ENT, general, hand & micro surgery, laparoscopic, laryngeal, more...
3T Medical Systems, LLC | Address: 31330 Schoolcraft Rd., No. 200, Livonia, Michigan 48150, USA
www.3tmedical.com | Send Inquiry | Phone: +1-(734)-525-9580, 800-741-5414
FDA Registration: 1836518
Products: Tubing, Cardiovasculars, Foley Catheters, Vessel Cannulation Forceps, 2 - Way Foley Balloon Catheter, 3 - Way Foley Balloon Catheter, ...
3T Medical Systems, LLC is a distributor of medical supplies. We provide healthcare products to end users including hospitals, extended care facilities, and large manufacturers. We also distribute a r more...
www.3tmedical.com | Send Inquiry | Phone: +1-(734)-525-9580, 800-741-5414
FDA Registration: 1836518
Products: Tubing, Cardiovasculars, Foley Catheters, Vessel Cannulation Forceps, 2 - Way Foley Balloon Catheter, 3 - Way Foley Balloon Catheter, ...
3T Medical Systems, LLC is a distributor of medical supplies. We provide healthcare products to end users including hospitals, extended care facilities, and large manufacturers. We also distribute a r more...
Alliant Healthcare Products | Address: 8850 M89, Richland, Michigan 49083, USA
www.allianthealthcare.com | Send Inquiry | Phone: +1-(269)-629-0300, 888-307-1144
FDA Registration: 3004986960
Products: Foley Catheters, Foley Catheter Insertion Trays, Foley Balloon Catheters, Foley Catheter Insertion Kits, Closed Wound Drainage Systems, Bulb Closed Wound Drainage Systems, ...
Alliant Healthcare Products designs, develops, manufactures and markets products for the healthcare market. We also provide custom assembly, packaging and manufacturing for acute care hospitals, gover more...
www.allianthealthcare.com | Send Inquiry | Phone: +1-(269)-629-0300, 888-307-1144
FDA Registration: 3004986960
Products: Foley Catheters, Foley Catheter Insertion Trays, Foley Balloon Catheters, Foley Catheter Insertion Kits, Closed Wound Drainage Systems, Bulb Closed Wound Drainage Systems, ...
Alliant Healthcare Products designs, develops, manufactures and markets products for the healthcare market. We also provide custom assembly, packaging and manufacturing for acute care hospitals, gover more...
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FDA Code / Regulation: GEJ / 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.
