Bone Mallets Suppliers
Limit companies to: Worldwide USA
Surgical Tools, Inc. | Address: 404-A Walnut Avenue SE, Roanoke, Virginia 24014, USA 
www.surgicaltools.com | Send Inquiry | Phone: 800.774.2040
FDA Registration: 1219153 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Insufflators, Gynecology Instruments, Vaginal Retractors (FDA Code: HDL), Uterine Scoops, Uterine Scissors, Endarterectomy Strippers, ...
Surgical Tools, Inc. offers instruments for all surgical specialties. We deal with anesthesia delivery systems, breathing circuits, face masks, forceps, laryngoscopes, mouth gags, cardiocascular instr more...
www.surgicaltools.com | Send Inquiry | Phone: 800.774.2040
FDA Registration: 1219153 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Insufflators, Gynecology Instruments, Vaginal Retractors (FDA Code: HDL), Uterine Scoops, Uterine Scissors, Endarterectomy Strippers, ...
Surgical Tools, Inc. offers instruments for all surgical specialties. We deal with anesthesia delivery systems, breathing circuits, face masks, forceps, laryngoscopes, mouth gags, cardiocascular instr more...
EBI Patient Care, Inc. | Address: 1 Electro-biology Blvd., Guaynabo 00657, USA
Phone: +1-(973)-299-9300
FDA Registration: 3003435252
Products: Probes (FDA Code: HXB), Arthroscopes (FDA Code: HRX), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Bone Mallets (FDA Code: HXL), Human Bone Rasps (FDA Code: HTR), ...
EBI Patient Care, Inc. provides braces thermal therapy devices, spinal endoscopic system and cast bandage. more...
Phone: +1-(973)-299-9300
FDA Registration: 3003435252
Products: Probes (FDA Code: HXB), Arthroscopes (FDA Code: HRX), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Bone Mallets (FDA Code: HXL), Human Bone Rasps (FDA Code: HTR), ...
EBI Patient Care, Inc. provides braces thermal therapy devices, spinal endoscopic system and cast bandage. more...
Zimmer Dental, Inc. | Address: 1900 Aston Ave., Carlsbad, California 92008, USA
www.zimmerdental.com | Phone: +1-(760)-929-4300, 800-854-7019
FDA Registration: 2023141 Year Established: 1927 Annual Revenues: USD 100-500 Million Employee Count: ~410 Quality: ISO 13485, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Arthroscopes (FDA Code: HRX), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), ...
Zimmer Dental, Inc. specializes in dental implant products. Our product portfolio comprises of root-form endosseous dental implants, prosthetic attachments for restoration, surgical instrumentation, c more...
www.zimmerdental.com | Phone: +1-(760)-929-4300, 800-854-7019
FDA Registration: 2023141 Year Established: 1927 Annual Revenues: USD 100-500 Million Employee Count: ~410 Quality: ISO 13485, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Arthroscopes (FDA Code: HRX), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), ...
Zimmer Dental, Inc. specializes in dental implant products. Our product portfolio comprises of root-form endosseous dental implants, prosthetic attachments for restoration, surgical instrumentation, c more...
Alphatec Spine, Inc. | Address: 5818 El Camino Real, Carlsbad, California 92008, USA
www.alphatecspine.com | Send Inquiry | Phone: +1-(760)-431-9286, 800-922-1356
FDA Registration: 2027467
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Trays (FDA Code: LRP), Surgical Retractor Systems (FDA Code: GAD), ...
Alphatec Spine, Inc. is a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, primarily focused on the aging spine. We have more...
www.alphatecspine.com | Send Inquiry | Phone: +1-(760)-431-9286, 800-922-1356
FDA Registration: 2027467
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Trays (FDA Code: LRP), Surgical Retractor Systems (FDA Code: GAD), ...
Alphatec Spine, Inc. is a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, primarily focused on the aging spine. We have more...
H & H Co. | Address: 4435 East Airport Dr., #108, Ontario, California 91761, USA
www.hhco.net | Send Inquiry | Phone: +1-(909)-390-0373, 800-491-9989
FDA Registration: 2085199 Year Established: 1985
Products: Elevators, Forceps (FDA Code: HTD), Micro Surgery Instruments, Calipers, Bone Mallets (FDA Code: HXL), Scalpel Handle (FDA Code: GDZ), ...
H & H Co. specializes in oral & maxillofacial surgery, periodontal, micro surgery and implant instruments. We also deal with quartz halogen & fiber optic headlamp systems, reconditioning & retipping o more...
www.hhco.net | Send Inquiry | Phone: +1-(909)-390-0373, 800-491-9989
FDA Registration: 2085199 Year Established: 1985
Products: Elevators, Forceps (FDA Code: HTD), Micro Surgery Instruments, Calipers, Bone Mallets (FDA Code: HXL), Scalpel Handle (FDA Code: GDZ), ...
H & H Co. specializes in oral & maxillofacial surgery, periodontal, micro surgery and implant instruments. We also deal with quartz halogen & fiber optic headlamp systems, reconditioning & retipping o 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: Curettes, Forceps (FDA Code: HTD), Retractors, Scissors, Gastroenterologic Needle Holder (FDA Code: FHQ), Wire Twisters (FDA Code: HXS), ...
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: Curettes, Forceps (FDA Code: HTD), Retractors, Scissors, Gastroenterologic Needle Holder (FDA Code: FHQ), Wire Twisters (FDA Code: HXS), ...
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...
Bio-Bridge Science, Inc. | Address: 1211 West 22nd St., Suite 615, Oak Brook, Illinois 60523, USA
www.bbsinstruments.com | Send Inquiry | Phone: +1-(630)-9280869
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Bone Hooks (FDA Code: KIK), ...
Bio-Bridge Science, Inc. is a provider of surgical and dental instruments. Our surgical instruments include surgical clamps, forceps, scalpel handles, scissors, tweezers and retractors. Our dental ins more...
www.bbsinstruments.com | Send Inquiry | Phone: +1-(630)-9280869
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Bone Hooks (FDA Code: KIK), ...
Bio-Bridge Science, Inc. is a provider of surgical and dental instruments. Our surgical instruments include surgical clamps, forceps, scalpel handles, scissors, tweezers and retractors. Our dental ins more...
Precision Medical Manufacturing Corporation | Address: 852 Seton Court, Wheeling, Illinois 60090, USA
www.precisionmm.com | Send Inquiry | Phone: +1-(847)-229-1551, 866-633-4626
FDA Registration: 1416666 Year Established: 1914 Employee Count: ~20
Products: Vaginal Retractors (FDA Code: HDL), Self-Retaining Retractors (FDA Code: FFO), Surgical Retractor Systems (FDA Code: GAD), Neurosurgical Head Holder (FDA Code: HBL), Bone Mallets (FDA Code: HXL), Tonsil Snares (FDA Code: KBZ), ...
Precision Medical Manufacturing Corporation specializes in offering various medical devices. Our products include manual retractor, metal vaginal speculum, neurosurgical head holder, self-retaining re more...
www.precisionmm.com | Send Inquiry | Phone: +1-(847)-229-1551, 866-633-4626
FDA Registration: 1416666 Year Established: 1914 Employee Count: ~20
Products: Vaginal Retractors (FDA Code: HDL), Self-Retaining Retractors (FDA Code: FFO), Surgical Retractor Systems (FDA Code: GAD), Neurosurgical Head Holder (FDA Code: HBL), Bone Mallets (FDA Code: HXL), Tonsil Snares (FDA Code: KBZ), ...
Precision Medical Manufacturing Corporation specializes in offering various medical devices. Our products include manual retractor, metal vaginal speculum, neurosurgical head holder, self-retaining re more...
Precision Surgical Intl., Inc. | Address: PO Box 726, Noblesville, Indiana 46061, USA
www.psint.net | Send Inquiry | Phone: +1-(317)-776-3843, 800-776-8493
FDA Registration: 3013682233 Year Established: 1993 Annual Revenues: < USD 1 Million
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Rongeurs, Iris Scissors, Bone Holding Forceps, Mayo Scissors, Metzenbaum Scissors, ...
Precision Surgical Intl., Inc. offers a full line of surgical instruments, instrument care products, and instrument repair services along with surgical accessories. We deal with instrument trays, need more...
www.psint.net | Send Inquiry | Phone: +1-(317)-776-3843, 800-776-8493
FDA Registration: 3013682233 Year Established: 1993 Annual Revenues: < USD 1 Million
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Rongeurs, Iris Scissors, Bone Holding Forceps, Mayo Scissors, Metzenbaum Scissors, ...
Precision Surgical Intl., Inc. offers a full line of surgical instruments, instrument care products, and instrument repair services along with surgical accessories. We deal with instrument trays, need more...
Bcs Machine Company, Inc. | Address: 1393 Progress Way Suite 903, Eldersburg, Maryland 21784, USA
www.bcsmachine.com | Send Inquiry | Phone: +1-(410)-5525452
FDA Registration: 1125743
Products: Bone Mallets (FDA Code: HXL), ...
Bcs Machine Company, Inc. provides machining services to the medical community. more...
www.bcsmachine.com | Send Inquiry | Phone: +1-(410)-5525452
FDA Registration: 1125743
Products: Bone Mallets (FDA Code: HXL), ...
Bcs Machine Company, Inc. provides machining services to the medical community. more...
Symmetry Medical Inc. | Address: New Bedford Industrial Park, New Bedford, Massachusetts 02745, USA
www.symmetrymedical.com | Phone: +1-(508)-998-4493
Products: Vaginal Retractors (FDA Code: HDL), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Instruments, Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), ...
Symmetry Medical Inc. manufactures implants, instruments and cases to orthopedic devices. We offer cases and trays that made of metal, plastic or hybrid. We provide forged, cast, machined and finished more...
www.symmetrymedical.com | Phone: +1-(508)-998-4493
Products: Vaginal Retractors (FDA Code: HDL), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Instruments, Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), ...
Symmetry Medical Inc. manufactures implants, instruments and cases to orthopedic devices. We offer cases and trays that made of metal, plastic or hybrid. We provide forged, cast, machined and finished more...
Mopec | Address: 21750 Coolidge Highway, Oak Park, Michigan 48237, USA
www.mopec.com | Send Inquiry | Phone: +1-(248)-291-2040
Products: Iris Forceps, Tissue Forceps, Single Prong Skin Hooks, Iris Scissors, Osteotomes, Fume Hoods, ...
Mopec is a supplier of pathology, histology, morgue and necropsy equipment, supplies. Our product line includes dissection instruments, blades, polyethylene dissecting boards and tungsten carbide scis more...
www.mopec.com | Send Inquiry | Phone: +1-(248)-291-2040
Products: Iris Forceps, Tissue Forceps, Single Prong Skin Hooks, Iris Scissors, Osteotomes, Fume Hoods, ...
Mopec is a supplier of pathology, histology, morgue and necropsy equipment, supplies. Our product line includes dissection instruments, blades, polyethylene dissecting boards and tungsten carbide scis more...
Rush Pin, LLC | Address: 1010 19th Avenue, Meridian, Mississippi 39301, USA
www.rushpin.com | Send Inquiry | Phone: +1-(601)-693-6344, 800-251-7874
Annual Revenues: < USD 1 Million
Products: Mallets, Extractors, Bone Mallets (FDA Code: HXL), Nail Extractors (FDA Code: HWB), Pin Surgical Driver (FDA Code: GFC), Bender (FDA Code: HXW), ...
Rush Pin, LLC is a manufacturer and distributor of medullary pins & instruments. Our Rush pinning system offers a method of fracture fixation requiring shorter hospital stays. Its correct usage ensure more...
www.rushpin.com | Send Inquiry | Phone: +1-(601)-693-6344, 800-251-7874
Annual Revenues: < USD 1 Million
Products: Mallets, Extractors, Bone Mallets (FDA Code: HXL), Nail Extractors (FDA Code: HWB), Pin Surgical Driver (FDA Code: GFC), Bender (FDA Code: HXW), ...
Rush Pin, LLC is a manufacturer and distributor of medullary pins & instruments. Our Rush pinning system offers a method of fracture fixation requiring shorter hospital stays. Its correct usage ensure more...
Ulrich Medical. | Address: 54 Spirit 40 Park Drive, Chesterfield, Missouri 63005, USA
www.ulrichmedical.com | Send Inquiry | Phone: +1-(866)-519-0268
FDA Registration: 9612420
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Ankle Distractors, General Surgical Instruments, ...
Ulrich Medical specializes in providing spiral implants, tourniquets, surgical instruments and family of cages products. Our Cosmic™ system provides stabilized suspension of the spinal segments a more...
www.ulrichmedical.com | Send Inquiry | Phone: +1-(866)-519-0268
FDA Registration: 9612420
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Ankle Distractors, General Surgical Instruments, ...
Ulrich Medical specializes in providing spiral implants, tourniquets, surgical instruments and family of cages products. Our Cosmic™ system provides stabilized suspension of the spinal segments a more...
Musculoskeletal Transplant Foundation | Address: 125 May St., Suite 300, Edison, New Jersey 08837, USA
www.mtf.org | Send Inquiry | Phone: +1-(732732)-661-0202
FDA Registration: 2249062
Products: Forceps (FDA Code: HTD), Bone Mallets (FDA Code: HXL), Bone Wax (FDA Code: MTJ), Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Tamps (FDA Code: HXG), ...
Musculoskeletal Transplant Foundation is a provider of allograft tissues. Our sports medicine tissues are available for ligament reconstruction, cartilage repair, and meniscal transplantation. We also more...
www.mtf.org | Send Inquiry | Phone: +1-(732732)-661-0202
FDA Registration: 2249062
Products: Forceps (FDA Code: HTD), Bone Mallets (FDA Code: HXL), Bone Wax (FDA Code: MTJ), Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Tamps (FDA Code: HXG), ...
Musculoskeletal Transplant Foundation is a provider of allograft tissues. Our sports medicine tissues are available for ligament reconstruction, cartilage repair, and meniscal transplantation. We also more...
J & J Instruments, Inc. | Address: 737 East Elizabeth Ave., Linden, New Jersey 07036, USA
www.jjinstruments.com | Send Inquiry | Phone: +1-(908)-4863800
FDA Registration: 2246990
Products: Anesthesia Equipment, Nasal Specula, Vaginal Speculums, Eye Dressing Forceps, Iris Tissue Forceps, Bone Mallets (FDA Code: HXL), ...
J & J Instruments, Inc. manufactures medical, dental and veterinary instruments. Our dental products include amalgam carrier, amalgam condensers and pluggers, burnishers, carvers, cotton & dressing fo more...
www.jjinstruments.com | Send Inquiry | Phone: +1-(908)-4863800
FDA Registration: 2246990
Products: Anesthesia Equipment, Nasal Specula, Vaginal Speculums, Eye Dressing Forceps, Iris Tissue Forceps, Bone Mallets (FDA Code: HXL), ...
J & J Instruments, Inc. manufactures medical, dental and veterinary instruments. Our dental products include amalgam carrier, amalgam condensers and pluggers, burnishers, carvers, cotton & dressing fo more...
Delta Surgical Instruments, Inc. | Address: 95 Schunnemunk Rd., Highland Mills, New York 10930, USA
www.deltasurgicalinstruments.com | Send Inquiry | Phone: +1-(845)-9283760
FDA Registration: 3005609209
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Bone Mallets (FDA Code: HXL), Human Bone Rasps (FDA Code: HTR), ...
Delta Surgical Instruments, Inc. manufactures dental surgical instruments. Our product line comprises of forceps, retractors, towel clamps, rasps, spinal punches, splinter forceps, sponge clamps, rong more...
www.deltasurgicalinstruments.com | Send Inquiry | Phone: +1-(845)-9283760
FDA Registration: 3005609209
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Bone Mallets (FDA Code: HXL), Human Bone Rasps (FDA Code: HTR), ...
Delta Surgical Instruments, Inc. manufactures dental surgical instruments. Our product line comprises of forceps, retractors, towel clamps, rasps, spinal punches, splinter forceps, sponge clamps, rong more...
Synthes (USA) | Address: 35 Airport Road, Horseheads, New York 14845, USA
www.synthes.com/html | Send Inquiry | Phone: +1-(610)-719-5000
FDA Registration: 3003506883 Year Established: 1974 Annual Revenues: > USD 1 Billion Employee Count: ~9000
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Arthroscopes (FDA Code: HRX), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), ...
Synthes (USA) is a medical device company. We develop, produce and market instruments, implants & biomaterials for the surgical fixation, correction and regeneration of the human skeleton & its soft t more...
www.synthes.com/html | Send Inquiry | Phone: +1-(610)-719-5000
FDA Registration: 3003506883 Year Established: 1974 Annual Revenues: > USD 1 Billion Employee Count: ~9000
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Arthroscopes (FDA Code: HRX), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), ...
Synthes (USA) is a medical device company. We develop, produce and market instruments, implants & biomaterials for the surgical fixation, correction and regeneration of the human skeleton & its soft t more...
Salvin Dental Specialties, Inc. | Address: 3450 Latrobe Drive, Charlotte, North Carolina 28211-4847, USA
www.salvin.com | Send Inquiry | Phone: +1-(704)-442-5400, 800-535-6566
FDA Registration: 1066741 Year Established: 1981 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Forceps (FDA Code: HTD), General Medical Supplies, Adult Cricothyrotomy Kit, Surgical Trays (FDA Code: LRP), Bone Mallets (FDA Code: HXL), Scalpel Handle (FDA Code: GDZ), ...
Salvin Dental Specialties, Inc. manufactures dental equipment. Our radiographic x-ray distortion markers are precise 5mm stainless balls that help to compensate for distortion on panoramic films. Our more...
www.salvin.com | Send Inquiry | Phone: +1-(704)-442-5400, 800-535-6566
FDA Registration: 1066741 Year Established: 1981 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Forceps (FDA Code: HTD), General Medical Supplies, Adult Cricothyrotomy Kit, Surgical Trays (FDA Code: LRP), Bone Mallets (FDA Code: HXL), Scalpel Handle (FDA Code: GDZ), ...
Salvin Dental Specialties, Inc. manufactures dental equipment. Our radiographic x-ray distortion markers are precise 5mm stainless balls that help to compensate for distortion on panoramic films. Our more...
Aesculap Implant Systems, Inc. | Address: #3773, Corporate Parkway, Center Valley, Pennsylvania 18034, USA
www.aesculapimplantsystems.com | Send Inquiry | Phone: +1-(610)-984-9081, 800-234-9179
FDA Registration: 3005739625
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Self-Retaining Retractors (FDA Code: FFO), Arthroscopes (FDA Code: HRX), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), ...
Aesculap Implant Systems, Inc. offers a complete line of implant systems and instrumentation for the spine & orthopedic markets. Our orthopedic products include OrthoPilot® navigation system, Colu more...
www.aesculapimplantsystems.com | Send Inquiry | Phone: +1-(610)-984-9081, 800-234-9179
FDA Registration: 3005739625
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Self-Retaining Retractors (FDA Code: FFO), Arthroscopes (FDA Code: HRX), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), ...
Aesculap Implant Systems, Inc. offers a complete line of implant systems and instrumentation for the spine & orthopedic markets. Our orthopedic products include OrthoPilot® navigation system, Colu more...
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FDA Code / Regulation: HXL / 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.
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