Scalpel Blade Suppliers
Limit companies to: Worldwide USA
Sable Industries | Address: 4751 Oceanside Blvd., Unit G, Oceanside, California 92056, USA 
Send Inquiry | Phone: +1-(760)-758-4553, 800-890-0251
Annual Revenues: < USD 1 Million Employee Count: ~10
Products: Dissecting Scalpel Blades, Cataract Knife, Single Handed Scalpel Blade Remover, Scalpel Blade (FDA Code: GES), Ophthalmic Scalpel, Cataract Knife, Laparoscopic Knife Blade, ...
Sable Industries specializes in knives and scalpel blades. more...
Send Inquiry | Phone: +1-(760)-758-4553, 800-890-0251
Annual Revenues: < USD 1 Million Employee Count: ~10
Products: Dissecting Scalpel Blades, Cataract Knife, Single Handed Scalpel Blade Remover, Scalpel Blade (FDA Code: GES), Ophthalmic Scalpel, Cataract Knife, Laparoscopic Knife Blade, ...
Sable Industries specializes in knives and scalpel blades. more...
Amsino International, Inc | Address: 855 Towne Center Drive, Pomona, California 91767, USA
www.amsino.com | Send Inquiry | Phone: +1-(906)-626-5888
FDA Registration: 2085175 Year Established: 1993 Annual Revenues: USD 25-50 Million Employee Count: ~500 Quality: ISO 9001, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Urine Collection Leg Bags (FDA Code: FAQ), IV Catheters & Infusion Sets, IV Sets, General EMT, ...
Amsino International, Inc is an ISO 9001 certified company. We manufacture disposable medical products. We specialize in urology, general feeding with irrigation, IV therapy products, surgical, genera more...
www.amsino.com | Send Inquiry | Phone: +1-(906)-626-5888
FDA Registration: 2085175 Year Established: 1993 Annual Revenues: USD 25-50 Million Employee Count: ~500 Quality: ISO 9001, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Urine Collection Leg Bags (FDA Code: FAQ), IV Catheters & Infusion Sets, IV Sets, General EMT, ...
Amsino International, Inc is an ISO 9001 certified company. We manufacture disposable medical products. We specialize in urology, general feeding with irrigation, IV therapy products, surgical, genera more...
PL Medical Co., LLC. | Address: 117 West Dudley Town Road, Bloomfield, Connecticut 06002, USA
www.plmedical.com | Send Inquiry | Phone: +1-(860)-243-2100
FDA Registration: 2435343 Quality: ISO 9002 Certified
Products: Blood Lancets, Mini Blades, Surgical Blades, IV Catheters & Infusion Sets, IV Catheters, Disposable Scalpels, ...
PL Medical Co., LLC. deals with the design, development and distribution of medical devices. Our product list comprises of X-ray cassettes, blood lancets, disposable scalpels, stitch removers and surg more...
www.plmedical.com | Send Inquiry | Phone: +1-(860)-243-2100
FDA Registration: 2435343 Quality: ISO 9002 Certified
Products: Blood Lancets, Mini Blades, Surgical Blades, IV Catheters & Infusion Sets, IV Catheters, Disposable Scalpels, ...
PL Medical Co., LLC. deals with the design, development and distribution of medical devices. Our product list comprises of X-ray cassettes, blood lancets, disposable scalpels, stitch removers and surg more...
Okay Industries, Inc. | Address: 200 Ellis St., P.O. Box 2470, New Britain, Connecticut 06050-2470, USA
www.okayind.com | Send Inquiry | Phone: +1-(860)-225-8707
Annual Revenues: USD 25-50 Million Employee Count: ~150 Quality: ISO 9001:2000, ISO 9002 Certified
Products: Blades, Surgical Blades, Surgical Staplers, Titanium Staples, Surgical Staplers, Stainless Steel Staples, Surgical Scissors, Scalpel Handle (FDA Code: GDZ), ...
Okay Industries, Inc. provides metal stampings for the medical, surgical, dental, and specialty industrial markets. Our Accu-Blade® technology uses proprietary CNC machinery that ensures high volu more...
www.okayind.com | Send Inquiry | Phone: +1-(860)-225-8707
Annual Revenues: USD 25-50 Million Employee Count: ~150 Quality: ISO 9001:2000, ISO 9002 Certified
Products: Blades, Surgical Blades, Surgical Staplers, Titanium Staples, Surgical Staplers, Stainless Steel Staples, Surgical Scissors, Scalpel Handle (FDA Code: GDZ), ...
Okay Industries, Inc. provides metal stampings for the medical, surgical, dental, and specialty industrial markets. Our Accu-Blade® technology uses proprietary CNC machinery that ensures high volu more...
Fen Dental Mfg., Inc. | Address: 2665 West 81st St., Hialeah, Florida 33016, USA
www.fendental.com | Send Inquiry | Phone: +1-(305)-556-5259
FDA Registration: 1058077
Products: Dental Needles, Dental Syringes, Scalpel Blade (FDA Code: GES), Polyamide Synthetic Non-Absorbable Suture (FDA Code: GAR), Polyethylene Synthetic Non-Absorbable Suture (FDA Code: GAT), Polypropylene Synthetic Non-Absorbable Suture (FDA Code: GAW), ...
Fen Dental Mfg., Inc. specializes in the production of dental products. Our products include FenLED, halogen curing units, Sunclave 1525SA, dental syringes, brushes for prophylaxis, dental handles and more...
www.fendental.com | Send Inquiry | Phone: +1-(305)-556-5259
FDA Registration: 1058077
Products: Dental Needles, Dental Syringes, Scalpel Blade (FDA Code: GES), Polyamide Synthetic Non-Absorbable Suture (FDA Code: GAR), Polyethylene Synthetic Non-Absorbable Suture (FDA Code: GAT), Polypropylene Synthetic Non-Absorbable Suture (FDA Code: GAW), ...
Fen Dental Mfg., Inc. specializes in the production of dental products. Our products include FenLED, halogen curing units, Sunclave 1525SA, dental syringes, brushes for prophylaxis, dental handles and more...
Centennial Products, Inc. | Address: PO Box 23905, Jacksonville, Florida 32216, USA
www.centennialproducts.com | Send Inquiry | Phone: +1-(904)-332-0404, 888-604-1004
Year Established: 1999 Annual Revenues: < USD 1 Million
Products: Aprons, Syringe/Needle Combos, Latex Gloves, Scalpel Handle (FDA Code: GDZ), Isolation Gowns, Non Latex Gloves, ...
Centennial Products, Inc. manufactures range of body bags (cadaver pouches). We also offer a variety of morgue, field, lab supplies and person protection products. Our product line includes body bags, more...
www.centennialproducts.com | Send Inquiry | Phone: +1-(904)-332-0404, 888-604-1004
Year Established: 1999 Annual Revenues: < USD 1 Million
Products: Aprons, Syringe/Needle Combos, Latex Gloves, Scalpel Handle (FDA Code: GDZ), Isolation Gowns, Non Latex Gloves, ...
Centennial Products, Inc. manufactures range of body bags (cadaver pouches). We also offer a variety of morgue, field, lab supplies and person protection products. Our product line includes body bags, 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...
Demetech Corp. | Address: 3530 N.w. 115th Ave., Miami, Florida 33178, USA
Phone: +1-(305)-597-5277
FDA Registration: 1064584
Products: Forceps (FDA Code: HTD), Scissors, Sutures, Gastroenterologic Needle Holder (FDA Code: FHQ), Cohesive Bandages, Blood Pressure Monitors, ...
Demetech Corp. offers medical products and equipment.Our products include disposable surgeon's gloves, cotton applicator, blood pressure monitors/kit, suture, polyglycolic acid, surgical nylon suture, more...
Phone: +1-(305)-597-5277
FDA Registration: 1064584
Products: Forceps (FDA Code: HTD), Scissors, Sutures, Gastroenterologic Needle Holder (FDA Code: FHQ), Cohesive Bandages, Blood Pressure Monitors, ...
Demetech Corp. offers medical products and equipment.Our products include disposable surgeon's gloves, cotton applicator, blood pressure monitors/kit, suture, polyglycolic acid, surgical nylon suture, more...
Deepak Products, Inc. | Address: 5220 N.W. 72nd Ave., Bay 15, Miami, Florida 33166, USA
www.deepakproducts.com | Send Inquiry | Phone: +1-(305)-482-9669
Products: Anesthetics, Tongue Depressors (FDA Code: FMA), Patient Examination Gowns and Capes (FDA Code: FME), Disinfectants & Germicides, Surgical Masks (FDA Code: FXX), Topical Anesthetics, ...
Deepak Products, Inc. specializes in the manufacture of topical anesthetics, fluoride gels, fluoride foams and prophylaxis paste. Our Gelato topical anesthetic gel provides temporary relief of pain du more...
www.deepakproducts.com | Send Inquiry | Phone: +1-(305)-482-9669
Products: Anesthetics, Tongue Depressors (FDA Code: FMA), Patient Examination Gowns and Capes (FDA Code: FME), Disinfectants & Germicides, Surgical Masks (FDA Code: FXX), Topical Anesthetics, ...
Deepak Products, Inc. specializes in the manufacture of topical anesthetics, fluoride gels, fluoride foams and prophylaxis paste. Our Gelato topical anesthetic gel provides temporary relief of pain du more...
Rece International Corp. | Address: 5881 N.W. 151st St., Ste. 111, Miami Lakes, Florida 33014, USA
Phone: +1-(305)-3626555
FDA Registration: 3003965134
Products: Oxygen Masks (FDA Code: BYG), Gastroenterologic Needle Holder (FDA Code: FHQ), Urine Collection Leg Bags (FDA Code: FAQ), Tongue Depressors (FDA Code: FMA), Infusion Catheter (FDA Code: JCY), Elastic Bandages (FDA Code: FQM), ...
Rece International Corp. provides surgical and medical equipments such as adult tongue depressors, blood collection lancets, elastic stockings, emesis basins, hydrophilic wound dressings, venturi low more...
Phone: +1-(305)-3626555
FDA Registration: 3003965134
Products: Oxygen Masks (FDA Code: BYG), Gastroenterologic Needle Holder (FDA Code: FHQ), Urine Collection Leg Bags (FDA Code: FAQ), Tongue Depressors (FDA Code: FMA), Infusion Catheter (FDA Code: JCY), Elastic Bandages (FDA Code: FQM), ...
Rece International Corp. provides surgical and medical equipments such as adult tongue depressors, blood collection lancets, elastic stockings, emesis basins, hydrophilic wound dressings, venturi low more...
United Medical Enterprises | Address: 4049 Allen Station Rd, Augusta, Georgia 30906, USA
Phone: +1-(757)-224-0177
FDA Registration: 1062201
Products: Tongue Depressors (FDA Code: FMA), Gauze Sponges, Elastic Bandages (FDA Code: FQM), Surgical Mask for Nurses, Surgical Masks (FDA Code: FXX), Cone Surgical Mask, ...
United Medical Enterprises is a manufacturer of surgical and medical instruments. We provide non woven gauze sponges, sterile and non sterile for external use. more...
Phone: +1-(757)-224-0177
FDA Registration: 1062201
Products: Tongue Depressors (FDA Code: FMA), Gauze Sponges, Elastic Bandages (FDA Code: FQM), Surgical Mask for Nurses, Surgical Masks (FDA Code: FXX), Cone Surgical Mask, ...
United Medical Enterprises is a manufacturer of surgical and medical instruments. We provide non woven gauze sponges, sterile and non sterile for external use. 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...
R Medical Inc. | Address: 28835 N. Herky Drive, Unit 101, Lake Bluff, Illinois 60044, USA
r-medicalinc.com | Send Inquiry | Phone: +1-(847)-816 1615
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), ...
R Medical Inc. provides instruments & equipment for both open surgery & for endoscopy. We specialize in Easy-port® trocars, the Rudolf laparoscopy system instruments with cameras and light sources more...
r-medicalinc.com | Send Inquiry | Phone: +1-(847)-816 1615
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), ...
R Medical Inc. provides instruments & equipment for both open surgery & for endoscopy. We specialize in Easy-port® trocars, the Rudolf laparoscopy system instruments with cameras and light sources more...
Medline Industries, Inc. | Address: One Medline Place, Mundelein, Illinois 60060, USA
www.medline.com | Send Inquiry | Phone: +1-(800)-633-5463
FDA Registration: 1417592 Year Established: 1966 Annual Revenues: < USD 1 Million Employee Count: ~6800 Quality: ISO 13485 and ISO 11135 Certified
Products: Oxygen Masks (FDA Code: BYG), Autoclaves, Forceps (FDA Code: HTD), Scissors, Instrument Stands, Thermometers, ...
Medline Industries, Inc. is a manufacturer and distributor of health care supplies & services. We provide products and services to the entire continuum of care, including hospitals, extended care faci more...
www.medline.com | Send Inquiry | Phone: +1-(800)-633-5463
FDA Registration: 1417592 Year Established: 1966 Annual Revenues: < USD 1 Million Employee Count: ~6800 Quality: ISO 13485 and ISO 11135 Certified
Products: Oxygen Masks (FDA Code: BYG), Autoclaves, Forceps (FDA Code: HTD), Scissors, Instrument Stands, Thermometers, ...
Medline Industries, Inc. is a manufacturer and distributor of health care supplies & services. We provide products and services to the entire continuum of care, including hospitals, extended care faci 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...
Surgipath Medical Ind., Inc. | Address: 5205 Route 12, P.O. Box 528, Richmond, Illinois 60071, USA
www.surgipath.com/us-en | Send Inquiry | Phone: +1-(815)-) 678-2000
FDA Registration: 1419341
Products: Laboratory Equipment, Scalpels, Scissors, Needles, Osteotomes, Stainers, ...
Surgipath Medical Ind., Inc. specializes in the development, manufacture and supply of quality product solutions for the anatomical pathology laboratory. We supply products and services to a vast rang more...
www.surgipath.com/us-en | Send Inquiry | Phone: +1-(815)-) 678-2000
FDA Registration: 1419341
Products: Laboratory Equipment, Scalpels, Scissors, Needles, Osteotomes, Stainers, ...
Surgipath Medical Ind., Inc. specializes in the development, manufacture and supply of quality product solutions for the anatomical pathology laboratory. We supply products and services to a vast rang 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...
Symmetry Medical USA, Inc. | Address: 486 West 350 North, Warsaw, Indiana 46582, USA
www.symmetrymedical.com/Products/Instruments/Default.aspx | Phone: +1-(574)-267-8700
FDA Registration: 1828464 Employee Count: ~1800
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Ophthalmology Forceps, Dissectors, Gastroenterologic Needle Holder (FDA Code: FHQ), Blade Holders, ...
Symmetry Medical USA, Inc. provides implants, instruments and cases to orthopedic device manufacturers. We also design, develop and produce products for companies in the arthroscopy, dental, laparosco more...
www.symmetrymedical.com/Products/Instruments/Default.aspx | Phone: +1-(574)-267-8700
FDA Registration: 1828464 Employee Count: ~1800
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Ophthalmology Forceps, Dissectors, Gastroenterologic Needle Holder (FDA Code: FHQ), Blade Holders, ...
Symmetry Medical USA, Inc. provides implants, instruments and cases to orthopedic device manufacturers. We also design, develop and produce products for companies in the arthroscopy, dental, laparosco more...
ACE Surgical Supply Co., Inc. | Address: 1034 Pearl St., Brockton, Massachusetts 02301, USA
www.acesurgical.com | Send Inquiry | Phone: +1-(508)-588-3100, 800-441-3100
FDA Registration: 1287163 Annual Revenues: USD 10-25 Million Employee Count: ~50 Quality: ISO 9001, CE Certified
Products: Sterilizers, Non Dental Irrigating Syringe (FDA Code: KYZ), Scalpel Blade (FDA Code: GES), Pneumatic-Powered Surgical Instrument Motor (FDA Code: GET), Collagen Wound Dressing (FDA Code: KGN), General Surgery Tray (FDA Code: LRO), ...
ACE Surgical Supply Co., Inc. specializes in the development and manufacture of various dental products. Osteocel is an allograft cellular bone matrix retaining native mesenchymal stem cells (MSCs) an more...
www.acesurgical.com | Send Inquiry | Phone: +1-(508)-588-3100, 800-441-3100
FDA Registration: 1287163 Annual Revenues: USD 10-25 Million Employee Count: ~50 Quality: ISO 9001, CE Certified
Products: Sterilizers, Non Dental Irrigating Syringe (FDA Code: KYZ), Scalpel Blade (FDA Code: GES), Pneumatic-Powered Surgical Instrument Motor (FDA Code: GET), Collagen Wound Dressing (FDA Code: KGN), General Surgery Tray (FDA Code: LRO), ...
ACE Surgical Supply Co., Inc. specializes in the development and manufacture of various dental products. Osteocel is an allograft cellular bone matrix retaining native mesenchymal stem cells (MSCs) an more...
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FDA Code / Regulation: GES / 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.
