One-Piece Scalpel Suppliers
Limit companies to: Worldwide USA
Medisiss | Address: 2747 Sw 6th Street, Redmond, Oregon 97756, USA 
www.medisiss.com | Send Inquiry | Phone: +1-(541)-923-3310,866-866-7477
FDA Registration: 3032391
Products: Arthroscopes (FDA Code: HRX), Bone Rasps (FDA Code: HTR), Pneumatic Tourniquet (FDA Code: KCY), Surgical Sterilizing Aids, Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), ...
Medisiss is a registered third-party medical device reprocessor of single-use devices (SUDs).Our service list encompasses the cleaning, testing, refurbishing, sterilizing and packaging of both re-usab more...
www.medisiss.com | Send Inquiry | Phone: +1-(541)-923-3310,866-866-7477
FDA Registration: 3032391
Products: Arthroscopes (FDA Code: HRX), Bone Rasps (FDA Code: HTR), Pneumatic Tourniquet (FDA Code: KCY), Surgical Sterilizing Aids, Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), ...
Medisiss is a registered third-party medical device reprocessor of single-use devices (SUDs).Our service list encompasses the cleaning, testing, refurbishing, sterilizing and packaging of both re-usab 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...
Tactical Medical Solutions, Inc. | Address: 112 North Park Drive, Anderson, South Carolina 29625, USA
www.tacmedsolutions.com | Send Inquiry | Phone: +1-(864)-224-0081, 888-822-6331
FDA Registration: 3005853033
Products: Cricothyrotomy Kits (FDA Code: OGP), Tongue Depressors (FDA Code: FMA), Surgical Retractor Systems (FDA Code: GAD), Compression Dressing (FDA Code: MHW), Infant Tongue Depressor (FDA Code: FMA), Adult Tongue Depressor (FDA Code: FMA), ...
Tactical Medical Solutions, Inc. develops & supplies equipment for combat and tactical medicine. Our products include hemorrhage control, airway/breathing, circulation, casualty evacuation and hypothe more...
www.tacmedsolutions.com | Send Inquiry | Phone: +1-(864)-224-0081, 888-822-6331
FDA Registration: 3005853033
Products: Cricothyrotomy Kits (FDA Code: OGP), Tongue Depressors (FDA Code: FMA), Surgical Retractor Systems (FDA Code: GAD), Compression Dressing (FDA Code: MHW), Infant Tongue Depressor (FDA Code: FMA), Adult Tongue Depressor (FDA Code: FMA), ...
Tactical Medical Solutions, Inc. develops & supplies equipment for combat and tactical medicine. Our products include hemorrhage control, airway/breathing, circulation, casualty evacuation and hypothe more...
Deroyal Technologies, Inc. | Address: 1211 Hwy. 33 South, New Tazewell, Tennessee 37825, USA
Phone: +1-(865)-938-7828
Products: Urinary Leg Bags, Esophageal Stethoscopes (FDA Code: BZW), Urine Collection Leg Bags (FDA Code: FAQ), Surgical Drapes & Packs (FDA Code: KKX), Blood pressure Cuffs (FDA Code: DXQ), Surgical Staplers, Circular Staplers, ...
Deroyal Technologies, Inc. offers blood pressure monitors and various types of surgical staplers. Our products include bulb syringe, ear syringe, suction canister, skin marker, therapeutic cooling uni more...
Phone: +1-(865)-938-7828
Products: Urinary Leg Bags, Esophageal Stethoscopes (FDA Code: BZW), Urine Collection Leg Bags (FDA Code: FAQ), Surgical Drapes & Packs (FDA Code: KKX), Blood pressure Cuffs (FDA Code: DXQ), Surgical Staplers, Circular Staplers, ...
Deroyal Technologies, Inc. offers blood pressure monitors and various types of surgical staplers. Our products include bulb syringe, ear syringe, suction canister, skin marker, therapeutic cooling uni more...
C&a Scientific Co. | Address: 7241 Gabe Court, Manassas, Virginia 20109-2434, USA
www.cnascientific.com | Send Inquiry | Phone: +001-(703)-330-1413
FDA Registration: 1122839 Year Established: 1990 Annual Revenues: USD 1-5 Million Quality: ISO 9001, ISO 9002 Certified
Products: Blood Lancets, Microscope Filter Sets, Blood Collect Tubes, Microscopes, General Medical Supplies, General Surgery Supplies, ...
C&a Scientific Co. produces blood collect tubes, microscopes, pipettors, pipettes, light sources, microscope light source, operating microscope filters, fixed filters, operating microscope filters, tw more...
www.cnascientific.com | Send Inquiry | Phone: +001-(703)-330-1413
FDA Registration: 1122839 Year Established: 1990 Annual Revenues: USD 1-5 Million Quality: ISO 9001, ISO 9002 Certified
Products: Blood Lancets, Microscope Filter Sets, Blood Collect Tubes, Microscopes, General Medical Supplies, General Surgery Supplies, ...
C&a Scientific Co. produces blood collect tubes, microscopes, pipettors, pipettes, light sources, microscope light source, operating microscope filters, fixed filters, operating microscope filters, tw more...
Personna American Safety Razor Company | Address: One Razor Blade Lane, Verona, Virginia 24482-0979, USA
www.asrco.com | Send Inquiry | Phone: +1-(540)-248-8000
FDA Registration: 1119522 Year Established: 1875 Annual Revenues: USD 100-500 Million Employee Count: ~450 Quality: ISO 9001, CE Certified
Products: Adhesive Strips & Patches, Surgical Blades, Surgical Handles, General Medical Supplies, Nail Nippers & Trimmers, Razors, ...
Personna American Safety Razor Company is a worldwide blade manufacturer. We make surgical blades & handles & introduce sterile stainless steel surgical blades. Our Low Profile 0.010 inch microtome bl more...
www.asrco.com | Send Inquiry | Phone: +1-(540)-248-8000
FDA Registration: 1119522 Year Established: 1875 Annual Revenues: USD 100-500 Million Employee Count: ~450 Quality: ISO 9001, CE Certified
Products: Adhesive Strips & Patches, Surgical Blades, Surgical Handles, General Medical Supplies, Nail Nippers & Trimmers, Razors, ...
Personna American Safety Razor Company is a worldwide blade manufacturer. We make surgical blades & handles & introduce sterile stainless steel surgical blades. Our Low Profile 0.010 inch microtome bl more...
Gynex Corporation | Address: 2789 - 152nd Avenue Ne, Redmond, Washington 98052, USA
www.gynex.com | Send Inquiry | Phone: +1-(425)-882-1179, 800-220-5988
FDA Registration: 3032109
Products: Colposcopes, Vaginal Retractors (FDA Code: HDL), Clamps, Forceps (FDA Code: HTD), Scissors, Tubing, ...
Gynex Corporation specializes in providing OB/GYN instruments and equipment to customers worldwide. We offer anesthetic, biopsy punches, clamps, cleaning supplies, colposcopes, curettes, dilators, fet more...
www.gynex.com | Send Inquiry | Phone: +1-(425)-882-1179, 800-220-5988
FDA Registration: 3032109
Products: Colposcopes, Vaginal Retractors (FDA Code: HDL), Clamps, Forceps (FDA Code: HTD), Scissors, Tubing, ...
Gynex Corporation specializes in providing OB/GYN instruments and equipment to customers worldwide. We offer anesthetic, biopsy punches, clamps, cleaning supplies, colposcopes, curettes, dilators, fet more...
Hospital & Homecare Imp. & Exp. Co., Ltd. | Address: Room 608-611, No.5 Zhongtai Int. Plaza, No.311 Middle of Jiangdong Rd, Central Business Dist, Nanjing, Jiangsu, China 
www.aline-medical.com | Send Inquiry | Phone: +86-(25)-84573232
FDA Registration: 3006897996
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Urine Collection Leg Bags (FDA Code: FAQ), Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), ...
Hospital & Homecare Imp. & Exp. Co., Ltd. is mainly engaged in medical product development, covering thousands of products within the medical field. We provide Surgical & Optical Instruments, Laborato more...
www.aline-medical.com | Send Inquiry | Phone: +86-(25)-84573232
FDA Registration: 3006897996
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Urine Collection Leg Bags (FDA Code: FAQ), Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), ...
Hospital & Homecare Imp. & Exp. Co., Ltd. is mainly engaged in medical product development, covering thousands of products within the medical field. We provide Surgical & Optical Instruments, Laborato more...
Maersk Medical Ltd. | Address: Nursery Works, Yorks, Little London Road, Sheffield S8 0UJ, United Kingdom 
Phone: +44-(114)-2551063
Annual Revenues: < USD 1 Million Employee Count: ~100 Quality: ISO 9001, CE Certified
Products: Suture Removal Kit (FDA Code: MCZ), Scalpel Handle (FDA Code: GDZ), Dissecting Scalpel Handle, Dissecting Scalpel Blades, Single Handed Scalpel Blade Remover, Titanium Beaver Scalpel Handle, ...
Maersk Medical Ltd. provides stainless steel sterile blades for single use. We also provide single-use stainless steel suture cutters. more...
Phone: +44-(114)-2551063
Annual Revenues: < USD 1 Million Employee Count: ~100 Quality: ISO 9001, CE Certified
Products: Suture Removal Kit (FDA Code: MCZ), Scalpel Handle (FDA Code: GDZ), Dissecting Scalpel Handle, Dissecting Scalpel Blades, Single Handed Scalpel Blade Remover, Titanium Beaver Scalpel Handle, ...
Maersk Medical Ltd. provides stainless steel sterile blades for single use. We also provide single-use stainless steel suture cutters. more...
Swann-morton Limited | Address: Owlerton Green, Sheffield, England S6 2BJ, United Kingdom
www.swann-morton.com | Send Inquiry | Phone: +44-(114)-234 4223
FDA Registration: 9611194 Year Established: 1932 Annual Revenues: USD 25-50 Million Employee Count: ~300 Quality: ISO 9001, ISO 9002, CE Certified
Products: Sickle Blades, Skin Grafting Instruments, Surgical Blades, Surgical Blade Handles, Scalpel Handle (FDA Code: GDZ), Surgical Equipment, Blades & Burrs, ...
Swann-morton Limited supplies surgical blades and handles for surgeons & health care professionals. We are an ISO certified company. Our blades can be used in minor surgery, oral surgery, implantology more...
www.swann-morton.com | Send Inquiry | Phone: +44-(114)-234 4223
FDA Registration: 9611194 Year Established: 1932 Annual Revenues: USD 25-50 Million Employee Count: ~300 Quality: ISO 9001, ISO 9002, CE Certified
Products: Sickle Blades, Skin Grafting Instruments, Surgical Blades, Surgical Blade Handles, Scalpel Handle (FDA Code: GDZ), Surgical Equipment, Blades & Burrs, ...
Swann-morton Limited supplies surgical blades and handles for surgeons & health care professionals. We are an ISO certified company. Our blades can be used in minor surgery, oral surgery, implantology more...
Granton Medical Ltd. | Address: Parkway Close , Parkway Industrial Estate, Sheffield, South Yorkshire S9 4WJ, United Kingdom
www.granton.co.uk | Send Inquiry | Phone: +44-(114)-275-7290
FDA Registration: 9680311 Quality: ISO 9001: 2000, ISO 13485:2003, CE Certified
Products: Scalpel Handle (FDA Code: GDZ), Dissecting Scalpel Handle, Dissecting Scalpel Blades, Adjustable Frequency Tuning Fork, Hertz Frequency Tuning Fork, Sensory Evaluation Tuning Fork, ...
Granton Medical Ltd. specializes in medical products such as self-seal sterilization pouches, tuning forks, scalpels, disposable gloves, dental laboratory knives, and palette knives. We also deal with more...
www.granton.co.uk | Send Inquiry | Phone: +44-(114)-275-7290
FDA Registration: 9680311 Quality: ISO 9001: 2000, ISO 13485:2003, CE Certified
Products: Scalpel Handle (FDA Code: GDZ), Dissecting Scalpel Handle, Dissecting Scalpel Blades, Adjustable Frequency Tuning Fork, Hertz Frequency Tuning Fork, Sensory Evaluation Tuning Fork, ...
Granton Medical Ltd. specializes in medical products such as self-seal sterilization pouches, tuning forks, scalpels, disposable gloves, dental laboratory knives, and palette knives. We also deal with more...
Kronring HB | Address: Skalby Gard, Vasteras 72476, Sweden
Phone: +46-(21)-352-555
Year Established: 1895 Annual Revenues: < USD 1 Million Employee Count: ~30
Products: Blood Lancets, Face Masks, Cytology Brushes, Aprons, Jars, Test Tubes, ...
Kronring HB specializes in offering various medical devices such as surgical accessories, optical aids, trays, operating equipment and endodontic instruments. We also offer accessories for dental equi more...
Phone: +46-(21)-352-555
Year Established: 1895 Annual Revenues: < USD 1 Million Employee Count: ~30
Products: Blood Lancets, Face Masks, Cytology Brushes, Aprons, Jars, Test Tubes, ...
Kronring HB specializes in offering various medical devices such as surgical accessories, optical aids, trays, operating equipment and endodontic instruments. We also offer accessories for dental equi more...
Harwill Medical Pty. Ltd. | Address: Po Box 552, Sanlamhof 7532, South Africa 
www.harmed.co.za | Send Inquiry | Phone: +27-(21)-370-4000
Annual Revenues: USD 10-25 Million Employee Count: ~200 Quality: ISO 9001, ISO 9002, CE Certified
Products: Tongue Depressors (FDA Code: FMA), Flavored Tongue Depressors, Sweetened Tongue Depressors, Used Tongue Depressors, Cardiorespiratory Monitor, Respiratory Monitors, ...
Harwill Medical Pty. Ltd. is a provider of medical devices. Medicine pacifier combines a pacifier with a unique patented syringe which allows for absolute trouble-free and precise administration of me more...
www.harmed.co.za | Send Inquiry | Phone: +27-(21)-370-4000
Annual Revenues: USD 10-25 Million Employee Count: ~200 Quality: ISO 9001, ISO 9002, CE Certified
Products: Tongue Depressors (FDA Code: FMA), Flavored Tongue Depressors, Sweetened Tongue Depressors, Used Tongue Depressors, Cardiorespiratory Monitor, Respiratory Monitors, ...
Harwill Medical Pty. Ltd. is a provider of medical devices. Medicine pacifier combines a pacifier with a unique patented syringe which allows for absolute trouble-free and precise administration of me more...
Fabryka Narzedzi Medycznych | Address: Ul. Mstowska 8 A, Rudniki K/czestochowy 42-240, Poland
www.chirmed.pl | Send Inquiry | Phone: +48-(34)-320-14-84
FDA Registration: 3005587147
Products: Forceps (FDA Code: HTD), Bone Rasps (FDA Code: HTR), Tongue Depressors (FDA Code: FMA), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), ...
Fabryka Narzedzi Medycznych manufactures surgical and medical instruments. more...
www.chirmed.pl | Send Inquiry | Phone: +48-(34)-320-14-84
FDA Registration: 3005587147
Products: Forceps (FDA Code: HTD), Bone Rasps (FDA Code: HTR), Tongue Depressors (FDA Code: FMA), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), ...
Fabryka Narzedzi Medycznych manufactures surgical and medical instruments. more...
Combined Instruments (Pvt.), Ltd. | Address: 13-A Model Town, Ugoki, Sailkot, Pakistan
Phone: +92-(432)-510243
Products: Vaginal Retractors (FDA Code: HDL), Blood Lancets, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Uterine Sound Instruments, Lacrimal Dilators and Cannulas, ...
Combined Instruments (Pvt.), Ltd. is a manufacturer and exporter of general surgery instruments. Our products include cotton applicators, scalpel blades, depth gauge, ear speculum holders, biopsy & su more...
Phone: +92-(432)-510243
Products: Vaginal Retractors (FDA Code: HDL), Blood Lancets, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Uterine Sound Instruments, Lacrimal Dilators and Cannulas, ...
Combined Instruments (Pvt.), Ltd. is a manufacturer and exporter of general surgery instruments. Our products include cotton applicators, scalpel blades, depth gauge, ear speculum holders, biopsy & su more...
Trans Pak Industries | Address: Uggoki Road, Sialkot 22161, Pakistan
Phone: +1-(708)-430-7777
Products: Uterine Sound Instruments, Obstetrical Forceps (FDA Code: HDA), Uterine Sound Devices, Vaginal Dilators (FDA Code: HDX), Titanium Ophthalmic Forceps, Scalpel Handle (FDA Code: GDZ), ...
Trans Pak Industries provides surgical and medical instruments. Our products include wire cutting scissors, tooth extraction forceps, umbilical scissors, percussion hammer, surgical handle, reusable s more...
Phone: +1-(708)-430-7777
Products: Uterine Sound Instruments, Obstetrical Forceps (FDA Code: HDA), Uterine Sound Devices, Vaginal Dilators (FDA Code: HDX), Titanium Ophthalmic Forceps, Scalpel Handle (FDA Code: GDZ), ...
Trans Pak Industries provides surgical and medical instruments. Our products include wire cutting scissors, tooth extraction forceps, umbilical scissors, percussion hammer, surgical handle, reusable s more...
Dynamic Surgical (Pvt.) Ltd. | Address: Wazirabad Rd. Ugoki Industrial Area, Ugoki, Sialkot 51050, Pakistan
dynamic-surgical.com | Send Inquiry | Phone: +92-(52)-3571374
Annual Revenues: < USD 1 Million Employee Count: ~70 Quality: ISO 9001:2000, ISO 13485, CE Certified
Products: Pelvimeters, Saws (FDA Code: HSO), Uterine Sound Instruments, Dressing Forceps, Fixation Forceps, Tissue Forceps, ...
Dynamic Surgical (Pvt.) Ltd. is a manufacturer and exporter of surgical, dental, cardiovascular, orthopedic, spinal & neurosurgical instruments & implants. Our product list comprises of hemostatic for more...
dynamic-surgical.com | Send Inquiry | Phone: +92-(52)-3571374
Annual Revenues: < USD 1 Million Employee Count: ~70 Quality: ISO 9001:2000, ISO 13485, CE Certified
Products: Pelvimeters, Saws (FDA Code: HSO), Uterine Sound Instruments, Dressing Forceps, Fixation Forceps, Tissue Forceps, ...
Dynamic Surgical (Pvt.) Ltd. is a manufacturer and exporter of surgical, dental, cardiovascular, orthopedic, spinal & neurosurgical instruments & implants. Our product list comprises of hemostatic for more...
Himalaya Trading Co. (Pvt) Ltd. | Address: Wazirabad Road, Rai Pur, Sialkot 51051, Pakistan
himalaya-trading.com | Send Inquiry | Phone: +92-(52)-3514021
Annual Revenues: USD 100-500 Million Employee Count: ~80
Products: Pelvimeters, Vaginal Retractors (FDA Code: HDL), Blood Lancets, Forceps (FDA Code: HTD), Retractors, Saws (FDA Code: HSO), ...
Himalaya Trading Co. (Pvt) Ltd. is a manufacturer & exporter of surgical, dental, manicure/pedicure and veterinary instruments. We also manufacture surgical hollow ware, knives of all sorts, scissors, more...
himalaya-trading.com | Send Inquiry | Phone: +92-(52)-3514021
Annual Revenues: USD 100-500 Million Employee Count: ~80
Products: Pelvimeters, Vaginal Retractors (FDA Code: HDL), Blood Lancets, Forceps (FDA Code: HTD), Retractors, Saws (FDA Code: HSO), ...
Himalaya Trading Co. (Pvt) Ltd. is a manufacturer & exporter of surgical, dental, manicure/pedicure and veterinary instruments. We also manufacture surgical hollow ware, knives of all sorts, scissors, more...
M.J. Instruments Company (Pvt) Ltd. | Address: Small Industries Estate, Sialkot 22161, Pakistan
Phone: +92-(432)-256627
FDA Registration: 8043752
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), ...
M.J. Instruments Company (Pvt) Ltd. is a manufacturer of cutting forceps, biopsy forceps, rongeurs, and anoscopes. more...
Phone: +92-(432)-256627
FDA Registration: 8043752
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), ...
M.J. Instruments Company (Pvt) Ltd. is a manufacturer of cutting forceps, biopsy forceps, rongeurs, and anoscopes. more...
Kashmir Surgical Co. | Address: Maharaja Road, Sialkot 22161, Pakistan
Phone: +92-(52)-4586239, 4597140
FDA Registration: 8043753
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Surgical Retractor Systems (FDA Code: GAD), Ring Cutters (FDA Code: FNS), ...
Kashmir Surgical Co. are a manufacturer, exporter and global distributor of surgical, dental, veterinary, manicure & pedicure instruments. more...
Phone: +92-(52)-4586239, 4597140
FDA Registration: 8043753
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Surgical Retractor Systems (FDA Code: GAD), Ring Cutters (FDA Code: FNS), ...
Kashmir Surgical Co. are a manufacturer, exporter and global distributor of surgical, dental, veterinary, manicure & pedicure instruments. more...
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FDA Code / Regulation: GDX / 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.
