General & Plastic Surgery Surgical Rasp Suppliers
Limit companies to: Worldwide USA
Koros Usa, Inc. | Address: 610 Flinn Ave., Moorpark, California 93021, USA 
www.korosusa.com | Send Inquiry | Phone: +1-(805)-529-0825
FDA Registration: 2023918
Products: Probes (FDA Code: HXB), Retractors, Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Wire Twisters (FDA Code: HXS), Cervical Retractor System, ...
Koros Usa, Inc. is a supplier of surgical instruments. Our product line includes cardio & thoracic, neuro and orthopedic instruments, pro retractor sets, V-Track retractor sets & XL instruments. Our c more...
www.korosusa.com | Send Inquiry | Phone: +1-(805)-529-0825
FDA Registration: 2023918
Products: Probes (FDA Code: HXB), Retractors, Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Wire Twisters (FDA Code: HXS), Cervical Retractor System, ...
Koros Usa, Inc. is a supplier of surgical instruments. Our product line includes cardio & thoracic, neuro and orthopedic instruments, pro retractor sets, V-Track retractor sets & XL instruments. Our c 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: Forceps (FDA Code: HTD), Demineralized Bone Matrix, Lacrimal Probes (FDA Code: HNL), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Orbital Retractors, ...
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: Forceps (FDA Code: HTD), Demineralized Bone Matrix, Lacrimal Probes (FDA Code: HNL), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Orbital Retractors, ...
Biomet Microfixation manufactures a complete range of craniomaxillofacial products. We offer products for neurosurgical, plastic, oral & maxillofacial, craniofacial, pediatric, ENT and cardiothoracic more...
Zoll Dental | Address: 7450 North Natchez Ave., Niles, Illinois 60714, USA
www.zolldental.com | Send Inquiry | Phone: +1-(847)-647-1819
FDA Registration: 1422507
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Scissors, Gastroenterologic Needle Holder (FDA Code: FHQ), Lacrimal Probes (FDA Code: HNL), Wire Twisters (FDA Code: HXS), ...
Zoll Dental manufactures dental hand instruments. We provide re-tipping and re-sharpening services. Our products include dressing pliers, mirror handles, perio/hygiene instruments, operative instrumen more...
www.zolldental.com | Send Inquiry | Phone: +1-(847)-647-1819
FDA Registration: 1422507
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Scissors, Gastroenterologic Needle Holder (FDA Code: FHQ), Lacrimal Probes (FDA Code: HNL), Wire Twisters (FDA Code: HXS), ...
Zoll Dental manufactures dental hand instruments. We provide re-tipping and re-sharpening services. Our products include dressing pliers, mirror handles, perio/hygiene instruments, operative instrumen 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...
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, Vaginal Retractors (FDA Code: HDL), Micro Surgery Instruments, Bipolar Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), Retractor System, ...
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, Vaginal Retractors (FDA Code: HDL), Micro Surgery Instruments, Bipolar Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), Retractor System, ...
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...
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...
Holmed Corporation | Address: 40 Norfolk Avenue, South Easton, Massachusetts 2375, USA
www.holmed.net | Send Inquiry | Phone: +1-(508)-238-3351
FDA Registration: 1219518 Year Established: 1979 Annual Revenues: USD 5-10 Million Employee Count: ~60 Quality: CE Certified
Products: Curettes, Forceps (FDA Code: HTD), Bipolar Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), Lacrimal Probes (FDA Code: HNL), Bone Awls and Probes, ...
Holmed Corporation deals with the design and manufacture of orthopedic products. Our expertise includes the design & manufacture of hip, knee, shoulder, elbow, & spine instruments and spinal implants. more...
www.holmed.net | Send Inquiry | Phone: +1-(508)-238-3351
FDA Registration: 1219518 Year Established: 1979 Annual Revenues: USD 5-10 Million Employee Count: ~60 Quality: CE Certified
Products: Curettes, Forceps (FDA Code: HTD), Bipolar Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), Lacrimal Probes (FDA Code: HNL), Bone Awls and Probes, ...
Holmed Corporation deals with the design and manufacture of orthopedic products. Our expertise includes the design & manufacture of hip, knee, shoulder, elbow, & spine instruments and spinal implants. more...
Maxilon Laboratories, Inc. | Address: 105 State Rt. 101a, Unit 8, Amherst, New Hampshire 03031, USA
www.maxilon.com | Phone: +1-(603)-594-9300
FDA Registration: 1225686
Products: Instruments surgical, Surgical Instrument (Miscellaneous Medical), Bone Surgery Surgical Instrument, General & Plastic Surgery Surgical Rasp (FDA Code: GAC), Bone Grafting Instrument, ...
Maxilon Laboratories, Inc. is a manufacturer of surgical and medical instruments. Our ebner 502 grafter is a reusable instrument, and mx-grafter is a disposable sterile instrument for rapidly and pred more...
www.maxilon.com | Phone: +1-(603)-594-9300
FDA Registration: 1225686
Products: Instruments surgical, Surgical Instrument (Miscellaneous Medical), Bone Surgery Surgical Instrument, General & Plastic Surgery Surgical Rasp (FDA Code: GAC), Bone Grafting Instrument, ...
Maxilon Laboratories, Inc. is a manufacturer of surgical and medical instruments. Our ebner 502 grafter is a reusable instrument, and mx-grafter is a disposable sterile instrument for rapidly and pred more...
Buxton Biomedical, Inc. | Address: 15a Melaine Lane, Unit 7, East Hanover, New Jersey 07936, USA
Phone: +1-(913)-560-4848
FDA Registration: 2248030
Products: Splints, Forceps (FDA Code: HTD), Mallets, Probes (FDA Code: HXB), Retractors, Saws (FDA Code: HSO), ...
Buxton Biomedical, Inc. specializes in providing mallets, self-retaining retractors, bone tampers, calipers, cannulae, dissectors, forceps, goniometers, needle holders, splints, strippers and wire cut more...
Phone: +1-(913)-560-4848
FDA Registration: 2248030
Products: Splints, Forceps (FDA Code: HTD), Mallets, Probes (FDA Code: HXB), Retractors, Saws (FDA Code: HSO), ...
Buxton Biomedical, Inc. specializes in providing mallets, self-retaining retractors, bone tampers, calipers, cannulae, dissectors, forceps, goniometers, needle holders, splints, strippers and wire cut more...
A.M. Surgical, Inc. | Address: 290 East Main St. Suite 200, Smithtown, New York 11787, USA
Phone: +1-(631)-979-9777
FDA Registration: 2437731 Year Established: 1995
Products: Sterilization Tray, Endoscopic Suturing Devices (FDA Code: MFJ), Surgical Tables Accessories, Arm Protection Support, General & Plastic Surgery Surgical Cannula (FDA Code: GEA), General & Plastic Surgery Surgical Elevator (FDA Code: GEG), General & Plastic Surgery Surgical Rasp (FDA Code: GAC), ...
A.M. Surgical, Inc. develops and distributes invasive devices and surgical procedures. Our products include cross pin fixator for distal radius fractures, uniportal endoscopic carpal tunnel release, u more...
Phone: +1-(631)-979-9777
FDA Registration: 2437731 Year Established: 1995
Products: Sterilization Tray, Endoscopic Suturing Devices (FDA Code: MFJ), Surgical Tables Accessories, Arm Protection Support, General & Plastic Surgery Surgical Cannula (FDA Code: GEA), General & Plastic Surgery Surgical Elevator (FDA Code: GEG), General & Plastic Surgery Surgical Rasp (FDA Code: GAC), ...
A.M. Surgical, Inc. develops and distributes invasive devices and surgical procedures. Our products include cross pin fixator for distal radius fractures, uniportal endoscopic carpal tunnel release, u 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...
Vilex, Inc. | Address: 111 Moffitt Street, Mcminnville, Tennessee 37110, USA
www.vilex.com | Phone: +1-(931)-474-7550
FDA Registration: 1051526
Products: Cannulated Screws, Instruments surgical, Reciprocating Saw Blades, Oscillating Saw Blades, Sagittal Saw Blades, Saw Blades, ...
Vilex, Inc. specializes in products related to orthopedic and podiatric bone surgery. We offer a broad range of cannulated screws, locking & conventional plates, small joint implants, and ring & mono- more...
www.vilex.com | Phone: +1-(931)-474-7550
FDA Registration: 1051526
Products: Cannulated Screws, Instruments surgical, Reciprocating Saw Blades, Oscillating Saw Blades, Sagittal Saw Blades, Saw Blades, ...
Vilex, Inc. specializes in products related to orthopedic and podiatric bone surgery. We offer a broad range of cannulated screws, locking & conventional plates, small joint implants, and ring & mono- 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...
Eurocut, Ltd. | Address: 201 Newhall Road, Sheffield S9 2QJ, United Kingdom 
www.eurocut.co.uk | Phone: +44-(114)-2611811
Products: General & Plastic Surgery Surgical Rasp (FDA Code: GAC), Orthopedic Manual Surgical Instrument (FDA Code: LXH), ...
Eurocut, Ltd. provides orthopedic manual surgical instruments. more...
www.eurocut.co.uk | Phone: +44-(114)-2611811
Products: General & Plastic Surgery Surgical Rasp (FDA Code: GAC), Orthopedic Manual Surgical Instrument (FDA Code: LXH), ...
Eurocut, Ltd. provides orthopedic manual surgical instruments. more...
JMF (T) Group Co., Ltd. | Address: 75/74 Moo 11, Paholyothin Rd., Klongnueng, Klongluang, Pathunthanee, TH-13 12120, Thailand
Products: Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Hooks (FDA Code: KIK), Resectoscopes (FDA Code: FJL), Surgical Trays (FDA Code: LRP), ...
JMF (T) Group Co., Ltd. specializes in manufacturing OEM medical devices. We provide large & small fragment implants and instruments. We also offer surgical power tools, sterile container systems, max more...
Products: Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Hooks (FDA Code: KIK), Resectoscopes (FDA Code: FJL), Surgical Trays (FDA Code: LRP), ...
JMF (T) Group Co., Ltd. specializes in manufacturing OEM medical devices. We provide large & small fragment implants and instruments. We also offer surgical power tools, sterile container systems, max more...
Medos S.A. | Address: Rue Girardet 29, Le Locle CH 2400, Switzerland
Phone: +41-(56)-703 333
FDA Registration: 8031062
Products: Vaginal Retractors (FDA Code: HDL), Lacrimal Probes (FDA Code: HNL), Wire Twisters (FDA Code: HXS), Tongue Depressors (FDA Code: FMA), Vascular Clamps (FDA Code: DXC), Obstetrical Forceps (FDA Code: HDA), ...
Medos S.A. specializes in diagnostic and therapeutic products. We provide instruments for shunt system implantation, central nervous system shunts & valves and burr hole covers. more...
Phone: +41-(56)-703 333
FDA Registration: 8031062
Products: Vaginal Retractors (FDA Code: HDL), Lacrimal Probes (FDA Code: HNL), Wire Twisters (FDA Code: HXS), Tongue Depressors (FDA Code: FMA), Vascular Clamps (FDA Code: DXC), Obstetrical Forceps (FDA Code: HDA), ...
Medos S.A. specializes in diagnostic and therapeutic products. We provide instruments for shunt system implantation, central nervous system shunts & valves and burr hole covers. more...
OAO Kazan Medical Instruments Factory | Address: 12 Salih Sajdasheva, Kazan, Tatarstan 420021, Russian Federation
www.kmizmarket.ru | Send Inquiry | Phone: +7-(843)-221-93-22
Quality: ISO 9001:2000,ISO 13845:2003 Certified
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Surgical Retractor Systems (FDA Code: GAD), Lacrimal Dilator (FDA Code: HNW), Scalpel Handle (FDA Code: GDZ), ...
OAO Kazan Medical Instruments Factory is a manufacturer of dental instruments, general surgery instruments, microsurgical instruments & kits and polymer tools. We also offer products for urology, gyne more...
www.kmizmarket.ru | Send Inquiry | Phone: +7-(843)-221-93-22
Quality: ISO 9001:2000,ISO 13845:2003 Certified
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Surgical Retractor Systems (FDA Code: GAD), Lacrimal Dilator (FDA Code: HNW), Scalpel Handle (FDA Code: GDZ), ...
OAO Kazan Medical Instruments Factory is a manufacturer of dental instruments, general surgery instruments, microsurgical instruments & kits and polymer tools. We also offer products for urology, gyne more...
Medgal | Address: Ul. Waska 59, Bialystok 15-122, Poland
www.medgal.com.pl | Phone: +48-(566)-32344
Products: Probes (FDA Code: HXB), Surgical Retractor Systems (FDA Code: GAD), Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), ...
Medgal specializes in providing stainless steel surgical instruments, chisels, elevators, gouges, probes, rasps, retractors, spatula and osteotomes. more...
www.medgal.com.pl | Phone: +48-(566)-32344
Products: Probes (FDA Code: HXB), Surgical Retractor Systems (FDA Code: GAD), Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), ...
Medgal specializes in providing stainless steel surgical instruments, chisels, elevators, gouges, probes, rasps, retractors, spatula and osteotomes. more...
Accuray Surgicals Ltd. | Address: Lakson Square Bldg. #2, Sarwar Shaheed Rd., Karachi 74200, Pakistan
www.accuray.com.pk | Send Inquiry | Phone: +92-(21)-5681419
FDA Registration: 8040265 Year Established: 1981 Quality: ISO 9001:2000, ISO 13485:2003, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Self-Retaining Retractors (FDA Code: FFO), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), ...
Accuray Surgicals Ltd. deals with the manufacturing of surgical, dental and veterinary instruments. Our product list comprises of operating scissors, bandage scissors, thumb dressing forceps, retracto more...
www.accuray.com.pk | Send Inquiry | Phone: +92-(21)-5681419
FDA Registration: 8040265 Year Established: 1981 Quality: ISO 9001:2000, ISO 13485:2003, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Self-Retaining Retractors (FDA Code: FFO), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), ...
Accuray Surgicals Ltd. deals with the manufacturing of surgical, dental and veterinary instruments. Our product list comprises of operating scissors, bandage scissors, thumb dressing forceps, retracto more...
K.K. Metallic Industries | Address: 21/277, Maharaja Road, Sialkot 51310, Pakistan
www.kkmetallic.com | Send Inquiry | Phone: +92-(52)-4586239
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, Knee Self-Retaining Retractors, ...
K.K. Metallic Industries provides surgical instruments like forceps, obstetrical retractors, self-retaining pliers, surgical adapter to the cord, scissors, wire cutter, speculum, umbilical scissors, d more...
www.kkmetallic.com | Send Inquiry | Phone: +92-(52)-4586239
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, Knee Self-Retaining Retractors, ...
K.K. Metallic Industries provides surgical instruments like forceps, obstetrical retractors, self-retaining pliers, surgical adapter to the cord, scissors, wire cutter, speculum, umbilical scissors, d more...
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FDA Code / Regulation: GAC / 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.
