Disposable Surgical Instrument Kit Suppliers
Limit companies to: Worldwide USA
RD Medical Mfg. Inc. | Address: PO Box 899 Culebra, Puerto Rico 00775, USA 
www.rdmedical.com | Send Inquiry | Phone: +1-(787)-742-3800
Products: Suture Removal Kit (FDA Code: MCZ), Knot Pusher, Skin Staple Removal Kit, Laceration Trays, Dressing Change Tray, I.V. Start Kits (FDA Code: LRS), ...
RD Medical Mfg. Inc. designs and manufactures medical devices. Our products are IV administration sets, needleless IV administration sets, custom IV sets and kits & procedure trays. We have the capabi more...
www.rdmedical.com | Send Inquiry | Phone: +1-(787)-742-3800
Products: Suture Removal Kit (FDA Code: MCZ), Knot Pusher, Skin Staple Removal Kit, Laceration Trays, Dressing Change Tray, I.V. Start Kits (FDA Code: LRS), ...
RD Medical Mfg. Inc. designs and manufactures medical devices. Our products are IV administration sets, needleless IV administration sets, custom IV sets and kits & procedure trays. We have the capabi more...
Implant Logic Systems, Ltd. | Address: 2300 Riverchase Cntr., Birmingham, Alabama 11516, USA
www.implantlogic.com | Phone: +1-(205)-967.7880
Products: Sutures, Micro Surgical Instruments, Disposable Surgical Instrument Kit (FDA Code: KDD), Bone Fixation Screw (FDA Code: HWC), Radiological Image Processing System (FDA Code: LLZ), Titanium Abutments, ...
Implant Logic Systems, Ltd. is an oral reconstructive device company. We offer implants, biologic, instruments, virtual implant placement and prosthetic products. Our implants are available as tapered more...
www.implantlogic.com | Phone: +1-(205)-967.7880
Products: Sutures, Micro Surgical Instruments, Disposable Surgical Instrument Kit (FDA Code: KDD), Bone Fixation Screw (FDA Code: HWC), Radiological Image Processing System (FDA Code: LLZ), Titanium Abutments, ...
Implant Logic Systems, Ltd. is an oral reconstructive device company. We offer implants, biologic, instruments, virtual implant placement and prosthetic products. Our implants are available as tapered more...
Joimax, Inc. | Address: 275 E. Hacienda Avenue, Campbell, California 95008, USA
www.joimaxusa.com | Send Inquiry | Phone: +1-(408)-370-3005
FDA Registration: 3005042595
Products: Light Sources, Punches, Arthroscopes (FDA Code: HRX), Wire Twisters (FDA Code: HXS), Pulmonic Stenosis Clamps, Electrosurgical Systems, ...
Joimax, Inc. deals with endoscopic spinal surgery. We offer Tessys®, video twister™, C-camsource®, jIFP 2000™, Surgimax™ and JFM 1910™. Our Tessys® spinal stenosis more...
www.joimaxusa.com | Send Inquiry | Phone: +1-(408)-370-3005
FDA Registration: 3005042595
Products: Light Sources, Punches, Arthroscopes (FDA Code: HRX), Wire Twisters (FDA Code: HXS), Pulmonic Stenosis Clamps, Electrosurgical Systems, ...
Joimax, Inc. deals with endoscopic spinal surgery. We offer Tessys®, video twister™, C-camsource®, jIFP 2000™, Surgimax™ and JFM 1910™. Our Tessys® spinal stenosis more...
CP Medical, Inc. | Address: 21622 Surveyor Circle, Huntington Beach, California 92646, USA
www.cpmednet.com | Send Inquiry | Phone: +1-(714)-969-6818, 800-669-6973
FDA Registration: 3012164473 Year Established: 1981 Annual Revenues: USD 1-5 Million
Products: Stethoscopes, Clamps, Forceps (FDA Code: HTD), Scissors, Cleaning Solutions, Blood Tubing Sets, ...
CP Medical, Inc. specializes in offering hemodialysis solutions, powders and ancillary products to dialysis in the healthcare industry. We also offer a variety of modesty garments for visual imaging a more...
www.cpmednet.com | Send Inquiry | Phone: +1-(714)-969-6818, 800-669-6973
FDA Registration: 3012164473 Year Established: 1981 Annual Revenues: USD 1-5 Million
Products: Stethoscopes, Clamps, Forceps (FDA Code: HTD), Scissors, Cleaning Solutions, Blood Tubing Sets, ...
CP Medical, Inc. specializes in offering hemodialysis solutions, powders and ancillary products to dialysis in the healthcare industry. We also offer a variety of modesty garments for visual imaging a more...
Currie Medical Specialties, Inc. | Address: 730 East Los Angeles Avenue, Monrovia, California 91016-4250, USA
www.curriemedical.com | Send Inquiry | Phone: +1-(626)-303-3521, 800-669-3521
FDA Registration: 2023637 Annual Revenues: USD 5-10 Million Employee Count: ~100 Quality: ISO 9000 Certified
Products: Finger Splints, Surgical Trays (FDA Code: LRP), Cervical Collars, Sacro-Lumbar Support, Elastic Ankle Support, Knee Immobilizer, ...
Currie Medical Specialties, Inc. manufactures procedural trays and kits, quality orthopedic, neoprene products, alternating leg pressure system and microbiological lab. more...
www.curriemedical.com | Send Inquiry | Phone: +1-(626)-303-3521, 800-669-3521
FDA Registration: 2023637 Annual Revenues: USD 5-10 Million Employee Count: ~100 Quality: ISO 9000 Certified
Products: Finger Splints, Surgical Trays (FDA Code: LRP), Cervical Collars, Sacro-Lumbar Support, Elastic Ankle Support, Knee Immobilizer, ...
Currie Medical Specialties, Inc. manufactures procedural trays and kits, quality orthopedic, neoprene products, alternating leg pressure system and microbiological lab. more...
Bioseal Medical Packaging Concepts | Address: 167 W. Orangethrope Ave., Placentia, California 92870-6922, USA
www.biosealnet.com | Send Inquiry | Phone: +1-(714)-528-4695, 800-441-7325
FDA Registration: 2027062 Year Established: 1988 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: ISO Certified
Products: General Orthopedic Supplies, Tubular Elastic Bandages & Nets, Elastic Bandages (FDA Code: FQM), Adhesive Elastic Bandage Tape, Self Adhesive Elastic Bandage, Cotton Balls, ...
Bioseal Medical Packaging Concepts delivers custom packaging and sterilization services for single-use items in the operating room & beyond. We provide critical services to the healthcare industry, su more...
www.biosealnet.com | Send Inquiry | Phone: +1-(714)-528-4695, 800-441-7325
FDA Registration: 2027062 Year Established: 1988 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: ISO Certified
Products: General Orthopedic Supplies, Tubular Elastic Bandages & Nets, Elastic Bandages (FDA Code: FQM), Adhesive Elastic Bandage Tape, Self Adhesive Elastic Bandage, Cotton Balls, ...
Bioseal Medical Packaging Concepts delivers custom packaging and sterilization services for single-use items in the operating room & beyond. We provide critical services to the healthcare industry, su 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...
Highland Medical,Inc. | Address: 205 Aberdeen Drive, San Carlos, California 94070, USA
Phone: +1-(650)-801-4800
Products: Disposable Surgical Instrument Kit (FDA Code: KDD), General & Plastic Surgery Surgical Cannula (FDA Code: GEA), Reamer (FDA Code: HTO), Socket Positioner (FDA Code: KIL), ...
Highland Medical, Inc. focuses on disposable surgical instrument kits, general & plastic surgery surgical cannulas and reamers. more...
Phone: +1-(650)-801-4800
Products: Disposable Surgical Instrument Kit (FDA Code: KDD), General & Plastic Surgery Surgical Cannula (FDA Code: GEA), Reamer (FDA Code: HTO), Socket Positioner (FDA Code: KIL), ...
Highland Medical, Inc. focuses on disposable surgical instrument kits, general & plastic surgery surgical cannulas and reamers. more...
Qsum Biopsy Disposables LLC | Address: PO Box 18086, Boulder, Colorado 80308, USA
www.qsum.net | Phone: +1-(720)-304-2135 877-304-4446
FDA Registration: 3005675811
Products: Shoe Covers, Surgical Drapes & Packs (FDA Code: KKX), Disposable Scalpels, Surgical Drapes (FDA Code: KKX), Sterile Marking Pens, Ultrasound Gel, ...
Qsum Biopsy Disposables LLC provides medical device and disposable components. We focus on biopsy trays, draping and products for breast care. Our product line includes stereotactic, ultrasound, MRI & more...
www.qsum.net | Phone: +1-(720)-304-2135 877-304-4446
FDA Registration: 3005675811
Products: Shoe Covers, Surgical Drapes & Packs (FDA Code: KKX), Disposable Scalpels, Surgical Drapes (FDA Code: KKX), Sterile Marking Pens, Ultrasound Gel, ...
Qsum Biopsy Disposables LLC provides medical device and disposable components. We focus on biopsy trays, draping and products for breast care. Our product line includes stereotactic, ultrasound, MRI & more...
Acuderm, Inc | Address: 5370 NW Terrace, Fort Lauderdale, Florida 33309, USA
acuderm.com | Send Inquiry | Phone: +001-(800)-327-0015
FDA Registration: 1035236 Year Established: 1983 Annual Revenues: USD 5-10 Million Employee Count: ~70 Quality: ISO 9002, CE Certified
Products: Curettes, Forceps (FDA Code: HTD), Powered Surgical Laser Instrument (FDA Code: GEX), Biopsy Punches (FDA Code: FCI), Cauteries, Cold Sterilization Solution, ...
Acuderm, Inc markets quality specialty medical products, disposable instruments and dermatology supplies. Our product line includes punches, curettes, acu excisor, needle, syringes, sutures, hyfrecato more...
acuderm.com | Send Inquiry | Phone: +001-(800)-327-0015
FDA Registration: 1035236 Year Established: 1983 Annual Revenues: USD 5-10 Million Employee Count: ~70 Quality: ISO 9002, CE Certified
Products: Curettes, Forceps (FDA Code: HTD), Powered Surgical Laser Instrument (FDA Code: GEX), Biopsy Punches (FDA Code: FCI), Cauteries, Cold Sterilization Solution, ...
Acuderm, Inc markets quality specialty medical products, disposable instruments and dermatology supplies. Our product line includes punches, curettes, acu excisor, needle, syringes, sutures, hyfrecato more...
E.M. Adams Company, Inc. | Address: 7496 Commercial Circle, Ft. Pierce, Florida 34951, USA
www.emadamsco.com | Send Inquiry | Phone: +1-(800)-225-4788
FDA Registration: 1054786 Year Established: 1958 Annual Revenues: USD 5-10 Million
Products: General Medical Supplies, General Diagnostic Equipment, General Surgery Supplies, Rib & Abdomen Supports, Suturing Kits & Removal Kits, Thumb & Elbow Brace & Supports, ...
E.M. Adams Company, Inc. serves the health care industry. Our product categories are restraints, surgical kits, post mortem bags, cart covers and stretcher pads. Our stretcher pads are constructed of more...
www.emadamsco.com | Send Inquiry | Phone: +1-(800)-225-4788
FDA Registration: 1054786 Year Established: 1958 Annual Revenues: USD 5-10 Million
Products: General Medical Supplies, General Diagnostic Equipment, General Surgery Supplies, Rib & Abdomen Supports, Suturing Kits & Removal Kits, Thumb & Elbow Brace & Supports, ...
E.M. Adams Company, Inc. serves the health care industry. Our product categories are restraints, surgical kits, post mortem bags, cart covers and stretcher pads. Our stretcher pads are constructed of 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...
Keller Medical, Inc. | Address: 609 Se Central Parkway, Stuart, Florida 34994, USA
www.kellerfunnel.com | Send Inquiry | Phone: +1-(772)-219-9993
FDA Registration: 3007802878
Products: Breast Implant, Cohesive Silicone Gel, Silicone Gel Sheets, Disposable Surgical Instrument Kit (FDA Code: KDD), Silicone Gel Implants, Breast Implant Delivery Devices, ...
Keller Medical, Inc. specializes in the production of disposable surgical instrument kit. Our products include Keller Funnel™ and Propel the gel™ surgical kits. We provide silicone gel imp more...
www.kellerfunnel.com | Send Inquiry | Phone: +1-(772)-219-9993
FDA Registration: 3007802878
Products: Breast Implant, Cohesive Silicone Gel, Silicone Gel Sheets, Disposable Surgical Instrument Kit (FDA Code: KDD), Silicone Gel Implants, Breast Implant Delivery Devices, ...
Keller Medical, Inc. specializes in the production of disposable surgical instrument kit. Our products include Keller Funnel™ and Propel the gel™ surgical kits. We provide silicone gel imp more...
U-Ten Corporation | Address: 1286 Humbracht Cir, Bartlett, Illinois 60103-2051, USA
Phone: +1-(630)-289-8058
Year Established: 1994 Annual Revenues: < USD 1 Million Quality: ISO 9002, CE Certified
Products: Towels, Gauze Sponges, General Surgical Dressings, Cotton Filled Gauze Sponges, Surgical Dressings, Medical Equipment & Cart Dust Covers, ...
U-Ten Corporation offers towels, laparotomy sponges, cotton and non-woven gauze sponges, surgical dressings & apparel, surgical kits and packs, and equipment covers. more...
Phone: +1-(630)-289-8058
Year Established: 1994 Annual Revenues: < USD 1 Million Quality: ISO 9002, CE Certified
Products: Towels, Gauze Sponges, General Surgical Dressings, Cotton Filled Gauze Sponges, Surgical Dressings, Medical Equipment & Cart Dust Covers, ...
U-Ten Corporation offers towels, laparotomy sponges, cotton and non-woven gauze sponges, surgical dressings & apparel, surgical kits and packs, and equipment covers. 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...
Sterling Medical-Products Intl., Inc. | Address: 401 Market St., Prophetstown, Illinois 61277, USA
Phone: +1-(815)-537-5303
FDA Registration: 1422598
Products: Disposable Surgical Instrument (FDA Code: KDC), Disposable Surgical Instrument Kit (FDA Code: KDD), ...
Sterling Medical-Products Intl., Inc. is a manufacturer of disposable surgical instrument kits. more...
Phone: +1-(815)-537-5303
FDA Registration: 1422598
Products: Disposable Surgical Instrument (FDA Code: KDC), Disposable Surgical Instrument Kit (FDA Code: KDD), ...
Sterling Medical-Products Intl., Inc. is a manufacturer of disposable surgical instrument kits. more...
Innovasive Devices, Inc. | Address: 734 Forest St., Marlborough, Massachusetts 1752-3032, USA
Phone: +1-(508)-460-8229
Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Disposable Surgical Instrument Kit (FDA Code: KDD), General & Plastic Surgery Laparoscope (FDA Code: GCJ), General Purpose Electrosurgical Equipment, Bone Fixation Staple (FDA Code: JDR), Soft Tissue Non-Biodegradable Fixation Fastener (FDA Code: MBI), Peritoneoscope (FDA Code: GCG), ...
Innovasive Devices, Inc. offers suture fasteners and graspers. We also provide diagnostic instruments. more...
Phone: +1-(508)-460-8229
Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Disposable Surgical Instrument Kit (FDA Code: KDD), General & Plastic Surgery Laparoscope (FDA Code: GCJ), General Purpose Electrosurgical Equipment, Bone Fixation Staple (FDA Code: JDR), Soft Tissue Non-Biodegradable Fixation Fastener (FDA Code: MBI), Peritoneoscope (FDA Code: GCG), ...
Innovasive Devices, Inc. offers suture fasteners and graspers. We also provide diagnostic instruments. more...
Becton Dickinson And Co. | Address: 411 Waverley Oaks Rd., Waltham, Massachusetts 02452-8405, USA
www.bd.com/ophthalmology | Send Inquiry | Phone: +1-(781)-906-7900, 866-906-8080
FDA Registration: 1211998 Annual Revenues: USD 10-25 Million Employee Count: ~200
Products: Lacrimal Probes (FDA Code: HNL), Surgical Drapes & Packs (FDA Code: KKX), Surgical Drapes (FDA Code: KKX), Ring Cutters (FDA Code: FNS), Lacrimal Dilator (FDA Code: HNW), Scalpel Handle (FDA Code: GDZ), ...
Our products focus on cataract, refractive, surgery kits and other surgical products. Our cataract products include blades, knives, cannules, cystotomes, drapes, and fluid collection. Our surgical pro more...
www.bd.com/ophthalmology | Send Inquiry | Phone: +1-(781)-906-7900, 866-906-8080
FDA Registration: 1211998 Annual Revenues: USD 10-25 Million Employee Count: ~200
Products: Lacrimal Probes (FDA Code: HNL), Surgical Drapes & Packs (FDA Code: KKX), Surgical Drapes (FDA Code: KKX), Ring Cutters (FDA Code: FNS), Lacrimal Dilator (FDA Code: HNW), Scalpel Handle (FDA Code: GDZ), ...
Our products focus on cataract, refractive, surgery kits and other surgical products. Our cataract products include blades, knives, cannules, cystotomes, drapes, and fluid collection. Our surgical pro more...
Centurion Medical Products | Address: 301 Catrell Drive, Howell, Michigan 48843, USA
www.tshsc.com | Send Inquiry | Phone: +1-(516)-546-5400, 800-248-4058
FDA Registration: 1824619 Year Established: 1961 Employee Count: ~720 Quality: ISO 9000, ISO 9001, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Vaginal Retractors (FDA Code: HDL), Scissors, Iris Scissors, Urinary Leg Bags, Urine Collection Leg Bags (FDA Code: FAQ), ...
Centurion Medical Products provides a variety of custom procedure kits, trays and specialty products to hospitals, health care facilities, non acute alternate site & home care providers. All our facil more...
www.tshsc.com | Send Inquiry | Phone: +1-(516)-546-5400, 800-248-4058
FDA Registration: 1824619 Year Established: 1961 Employee Count: ~720 Quality: ISO 9000, ISO 9001, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Vaginal Retractors (FDA Code: HDL), Scissors, Iris Scissors, Urinary Leg Bags, Urine Collection Leg Bags (FDA Code: FAQ), ...
Centurion Medical Products provides a variety of custom procedure kits, trays and specialty products to hospitals, health care facilities, non acute alternate site & home care providers. All our facil more...
INRAD | Address: 4375 Donker Court S.E., Kentwood, Michigan 49512, USA
www.inradinc.com | Send Inquiry | Phone: +1-(616)-301-7800, 800-558-4647
FDA Registration: 1835568 Year Established: 1981 Annual Revenues: USD 5-10 Million Employee Count: ~10 Quality: ISO 9001, CE Certified
Products: Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Catheter Introducers, MULLINS, Biopsy Instruments (FDA Code: KNW), Aspiration Needles, Implantable Venous Access Catheter Introducer Kits, ...
Inrad is a developer, manufacturer and distributor of medical devices serving the radiology & biopsy markets. We help to reduce the uncertainty in diagnosis by creating devices that offer more precisi more...
www.inradinc.com | Send Inquiry | Phone: +1-(616)-301-7800, 800-558-4647
FDA Registration: 1835568 Year Established: 1981 Annual Revenues: USD 5-10 Million Employee Count: ~10 Quality: ISO 9001, CE Certified
Products: Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Catheter Introducers, MULLINS, Biopsy Instruments (FDA Code: KNW), Aspiration Needles, Implantable Venous Access Catheter Introducer Kits, ...
Inrad is a developer, manufacturer and distributor of medical devices serving the radiology & biopsy markets. We help to reduce the uncertainty in diagnosis by creating devices that offer more precisi more...
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FDA Code / Regulation: KDD / 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.
