Operating Room Scrub Brush Suppliers
Limit companies to: Worldwide USA
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...
C. R. Bard, Inc., Bard Medical Div. | Address: 8195 Industrial Blvd., Covington, Georgia 30209, USA
www.bardmedical.com | Send Inquiry | Phone: +1-(770)-784-6100, 800-526-4455
FDA Registration: 3006082230 Quality: ISO 9001 Certified
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Catheter Introducers (FDA Code: DYB), Arthroscopes (FDA Code: HRX), Electrode Cables (FDA Code: IKD), Urethral Catheters (FDA Code: GBM), Urine Collection Leg Bags (FDA Code: FAQ), ...
C. R. Bard, Inc., Bard Medical Div. provides products and services that meet the needs of healthcare providers & patients. We specialize in disease state management offering the industry's comprehensi more...
www.bardmedical.com | Send Inquiry | Phone: +1-(770)-784-6100, 800-526-4455
FDA Registration: 3006082230 Quality: ISO 9001 Certified
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Catheter Introducers (FDA Code: DYB), Arthroscopes (FDA Code: HRX), Electrode Cables (FDA Code: IKD), Urethral Catheters (FDA Code: GBM), Urine Collection Leg Bags (FDA Code: FAQ), ...
C. R. Bard, Inc., Bard Medical Div. provides products and services that meet the needs of healthcare providers & patients. We specialize in disease state management offering the industry's comprehensi more...
LSL Industries Inc. | Address: 5535 N Wolcott Ave, Chicago, Illinois 60640-1019, USA
www.lslhealthcare.com | Send Inquiry | Phone: +1-(773)-878-1100
FDA Registration: 1420054 Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~40 Quality: ISO Certified
Products: General Medical Supplies, Suturing Kits & Removal Kits, Central Venous Catheters, Adhesive Bandages (FDA Code: KGX), Suture Removal Kit (FDA Code: MCZ), Fracture Bedpans, ...
LSL Industries Inc. offers a wide variety of disposable medical devices, component parts, various hospital supplies, disposable kits and surgical procedure kits. We also offer drainage bags, preconnec more...
www.lslhealthcare.com | Send Inquiry | Phone: +1-(773)-878-1100
FDA Registration: 1420054 Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~40 Quality: ISO Certified
Products: General Medical Supplies, Suturing Kits & Removal Kits, Central Venous Catheters, Adhesive Bandages (FDA Code: KGX), Suture Removal Kit (FDA Code: MCZ), Fracture Bedpans, ...
LSL Industries Inc. offers a wide variety of disposable medical devices, component parts, various hospital supplies, disposable kits and surgical procedure kits. We also offer drainage bags, preconnec 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...
Gift Sales Company | Address: 513, South St. Francis, Wichita, Kansas 67202-4523, USA
www.giftsalescompany.net | Send Inquiry | Phone: +1-(316)-267-0671/800-992-0181
Products: Nitrile Gloves, Latex Gloves, Razor Blades, Operating Room Scrub Brush (FDA Code: GEC), Packaging Material, Vinyl Patient Examination Glove (FDA Code: LYZ), ...
Gift Sales Company offers janitorial supplies and bathroom cleaning equipments. We also provide toilet bowl deodorant blocks, urinal blocks, urinal screens, bowl brushes, plastic & metal dust pans and more...
www.giftsalescompany.net | Send Inquiry | Phone: +1-(316)-267-0671/800-992-0181
Products: Nitrile Gloves, Latex Gloves, Razor Blades, Operating Room Scrub Brush (FDA Code: GEC), Packaging Material, Vinyl Patient Examination Glove (FDA Code: LYZ), ...
Gift Sales Company offers janitorial supplies and bathroom cleaning equipments. We also provide toilet bowl deodorant blocks, urinal blocks, urinal screens, bowl brushes, plastic & metal dust pans and more...
NBM LLC | Address: 2604, River Green Circle, Louisville, Kentucky 40206, USA
Phone: +1-(502)-895-7503
Products: Operating Room Scrub Brush (FDA Code: GEC), ...
NBM LLC offers scrub brush-sponges. more...
Phone: +1-(502)-895-7503
Products: Operating Room Scrub Brush (FDA Code: GEC), ...
NBM LLC offers scrub brush-sponges. more...
CFI Medical Solutions | Address: 14241 Fenton Road, Fenton, Michigan 48430, USA
www.cfimedical.com | Send Inquiry | Phone: +1-(810)-750-5300
FDA Registration: 1825560 Year Established: 1970 Annual Revenues: USD 10-25 Million Employee Count: ~300 Quality: ISO 13485:2003, CE Certified
Products: Surgical Drapes & Packs (FDA Code: KKX), Elastic Bandages (FDA Code: FQM), Cuffing System, Surgical Drapes (FDA Code: KKX), Lumbar Roll, Backrest Adjustable Pad, ...
CFI Medical Solutions is a manufacturing powerhouse and a cutting-edge engineering resource for original equipment manufacturers (OEMs). Our product categories are medical imaging, operating accessori more...
www.cfimedical.com | Send Inquiry | Phone: +1-(810)-750-5300
FDA Registration: 1825560 Year Established: 1970 Annual Revenues: USD 10-25 Million Employee Count: ~300 Quality: ISO 13485:2003, CE Certified
Products: Surgical Drapes & Packs (FDA Code: KKX), Elastic Bandages (FDA Code: FQM), Cuffing System, Surgical Drapes (FDA Code: KKX), Lumbar Roll, Backrest Adjustable Pad, ...
CFI Medical Solutions is a manufacturing powerhouse and a cutting-edge engineering resource for original equipment manufacturers (OEMs). Our product categories are medical imaging, operating accessori 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...
Arjon Industries | Address: 7550 N. Broadway, St. Louis, Missouri 63147, USA
www.arjonindustries.com | Send Inquiry | Phone: +1-(314)-383-2879
Products: Adhesive Bandages (FDA Code: KGX), Surgical Caps (FDA Code: FYF), Non Dental Irrigating Syringe (FDA Code: KYZ), Blood Collection Lancet (FDA Code: FMK), Isotonic Solution (FDA Code: JCE), Conductive Shoe and Shoe Cover (FDA Code: BWP), ...
Arjon Industries deals with Kitpackers systems. Our kits are customizable, pursuant to end-user specifications, and samples are readily available for clinical evaluations. Our products include cathete more...
www.arjonindustries.com | Send Inquiry | Phone: +1-(314)-383-2879
Products: Adhesive Bandages (FDA Code: KGX), Surgical Caps (FDA Code: FYF), Non Dental Irrigating Syringe (FDA Code: KYZ), Blood Collection Lancet (FDA Code: FMK), Isotonic Solution (FDA Code: JCE), Conductive Shoe and Shoe Cover (FDA Code: BWP), ...
Arjon Industries deals with Kitpackers systems. Our kits are customizable, pursuant to end-user specifications, and samples are readily available for clinical evaluations. Our products include cathete more...
Professional Disposables International, Inc., | Address: Two Nice-Pak Park, Orangeburg, New York 10962, USA
www.pdipdi.com | Send Inquiry | Phone: +1-(845)-365-1700
FDA Registration: 2411192 Year Established: 1977 Annual Revenues: USD 25-50 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Baby Care Items, Chairs & stools, Exam Tables, General Medical Supplies, Medical Exam Tables, Pediatric Exam Tables, ...
Professional Disposables International, Inc. specializes in wet wipe products. Our lemon glycerin swabstick 1 provides oral lubrication and stimulates saliva, which is effecitve for patients with parc more...
www.pdipdi.com | Send Inquiry | Phone: +1-(845)-365-1700
FDA Registration: 2411192 Year Established: 1977 Annual Revenues: USD 25-50 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Baby Care Items, Chairs & stools, Exam Tables, General Medical Supplies, Medical Exam Tables, Pediatric Exam Tables, ...
Professional Disposables International, Inc. specializes in wet wipe products. Our lemon glycerin swabstick 1 provides oral lubrication and stimulates saliva, which is effecitve for patients with parc more...
Steris Corporation | Address: 5960 Heisley Road, Mentor, Ohio 44060-1834, USA
www.steris.com | Send Inquiry | Phone: +1-(440)-354-2600
FDA Registration: 1527821 Year Established: 1987 Annual Revenues: > USD 1 Billion Employee Count: ~5100 Quality: ISO 9001, CE Certified
Products: Autoclaves, Chemical Sterilizers (FDA Code: MLR), Surgical Equipment, Fracture Tables, OR Tables, Table Extensions, ...
Steris Corporation offers a wide range of infection protection & contamination control products, including sterile processing solutions, surgical equipment such as surgical lights & tables, and labora more...
www.steris.com | Send Inquiry | Phone: +1-(440)-354-2600
FDA Registration: 1527821 Year Established: 1987 Annual Revenues: > USD 1 Billion Employee Count: ~5100 Quality: ISO 9001, CE Certified
Products: Autoclaves, Chemical Sterilizers (FDA Code: MLR), Surgical Equipment, Fracture Tables, OR Tables, Table Extensions, ...
Steris Corporation offers a wide range of infection protection & contamination control products, including sterile processing solutions, surgical equipment such as surgical lights & tables, and labora more...
Bausch & Lomb Inc. | Address: 8507 Pelham Rd., Greenville, South Carolina 29615-9598, USA
Phone: +1-(585)-338-6000
FDA Registration: 1032500
Products: Daily Wear Soft Contact Lenses (FDA Code: LPL), Extended Wear Soft Contact Lenses (FDA Code: LPM), Lacrimal Probes (FDA Code: HNL), Powered Surgical Laser Instrument (FDA Code: GEX), Contact Lens (FDA Code: HQD), Surgical Drapes & Packs (FDA Code: KKX), ...
Bausch & Lomb Inc. specializes in offering contact lens and contact lens care products. more...
Phone: +1-(585)-338-6000
FDA Registration: 1032500
Products: Daily Wear Soft Contact Lenses (FDA Code: LPL), Extended Wear Soft Contact Lenses (FDA Code: LPM), Lacrimal Probes (FDA Code: HNL), Powered Surgical Laser Instrument (FDA Code: GEX), Contact Lens (FDA Code: HQD), Surgical Drapes & Packs (FDA Code: KKX), ...
Bausch & Lomb Inc. specializes in offering contact lens and contact lens care products. more...
Team Technologies, Inc. | Address: 5949 Commerce Blvd., Morristown, Tennessee 37814, USA
www.teamtechinc.net | Send Inquiry | Phone: +1-(423)-587-2199
FDA Registration: 1051594 Quality: ISO 9001:2000 Certified
Products: Cytology Brushes, Toothbrushes, Suction Swab Kit, Medical Foam Swabs, Tracheobronchial Suction Catheter (FDA Code: BSY), Operating Room Scrub Brush (FDA Code: GEC), ...
Team Technologies, Inc. is a manufacturer of dental, medical, cosmetic, and industrial products. Our product area includes tooth brushes, toothpaste & denture adhesive, disposable prophy angles & prop more...
www.teamtechinc.net | Send Inquiry | Phone: +1-(423)-587-2199
FDA Registration: 1051594 Quality: ISO 9001:2000 Certified
Products: Cytology Brushes, Toothbrushes, Suction Swab Kit, Medical Foam Swabs, Tracheobronchial Suction Catheter (FDA Code: BSY), Operating Room Scrub Brush (FDA Code: GEC), ...
Team Technologies, Inc. is a manufacturer of dental, medical, cosmetic, and industrial products. Our product area includes tooth brushes, toothpaste & denture adhesive, disposable prophy angles & prop more...
Niko Surgical Ltd. | Address: Stroudwater Bus. Park, Unit 3 Brunel Way, Stroudwater Business Park, Stonehouse GL10 3SX, United Kingdom 
Phone: 1453/827-696
Annual Revenues: USD 5-10 Million Employee Count: ~160
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Surgical Marking Pens (FDA Code: HRP), Suction Tubes, Ferguson-Frazier Suction Tubes, Urine Collection Leg Bags (FDA Code: FAQ), ...
Niko Surgical Ltd. deals with electrodes, fixations, and orthopedics. more...
Phone: 1453/827-696
Annual Revenues: USD 5-10 Million Employee Count: ~160
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Surgical Marking Pens (FDA Code: HRP), Suction Tubes, Ferguson-Frazier Suction Tubes, Urine Collection Leg Bags (FDA Code: FAQ), ...
Niko Surgical Ltd. deals with electrodes, fixations, and orthopedics. more...
Allegiance Healthcare (thailand) Limited | Address: 7/111 Moo 4 Highway# 331, Mabyangporn, Pluakdaeng, Rayong 21140, Thailand
Send Inquiry | Phone: +66-(38)-956-155-62
FDA Registration: 9615914
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Arthroscopes (FDA Code: HRX), Surgical Drapes & Packs (FDA Code: KKX), Catheter Accessories (FDA Code: KGZ), ...
Allegiance Healthcare (Thailand) Limited, is a manufacturer of surgical and medical gloves. more...
Send Inquiry | Phone: +66-(38)-956-155-62
FDA Registration: 9615914
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Arthroscopes (FDA Code: HRX), Surgical Drapes & Packs (FDA Code: KKX), Catheter Accessories (FDA Code: KGZ), ...
Allegiance Healthcare (Thailand) Limited, is a manufacturer of surgical and medical gloves. 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...
Sunningdale Tech Ltd | Address: 51Joo Koon Circle, Singapore 629096, Singapore
www.sdaletech.com | Send Inquiry | Phone: +65-(6862)-2168
Products: Healthcare Service, Plastics Injection Molding, Operating Room Scrub Brush (FDA Code: GEC), Contract Manufacturing, Turn-Key Medical Device Manufacturing, ...
Sunningdale Tech Ltd is engaged in medical device manufacturing and healthcare services. We offer plastic injection molding services. more...
www.sdaletech.com | Send Inquiry | Phone: +65-(6862)-2168
Products: Healthcare Service, Plastics Injection Molding, Operating Room Scrub Brush (FDA Code: GEC), Contract Manufacturing, Turn-Key Medical Device Manufacturing, ...
Sunningdale Tech Ltd is engaged in medical device manufacturing and healthcare services. We offer plastic injection molding services. more...
The National Medical Products Co., Ltd. | Address: Al Kharj Road, Second Industrial City, Riyadh 11472, Saudi Arabia
www.damad.com | Send Inquiry | Phone: +966-(1)-4981666
FDA Registration: 1000342847 Year Established: 1979
Products: Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Nasopharyngeal Airways (FDA Code: BTQ), Arm Slings (FDA Code: ILI), Traction Accessories, Leg Straps (FDA Code: ILZ), ...
The National Medical Products Co., Ltd. is a manufacturer of CSSD, orthopedic, tapes and bandage products. We also offer wound care medical products, operating theater products, and patient care produ more...
www.damad.com | Send Inquiry | Phone: +966-(1)-4981666
FDA Registration: 1000342847 Year Established: 1979
Products: Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Nasopharyngeal Airways (FDA Code: BTQ), Arm Slings (FDA Code: ILI), Traction Accessories, Leg Straps (FDA Code: ILZ), ...
The National Medical Products Co., Ltd. is a manufacturer of CSSD, orthopedic, tapes and bandage products. We also offer wound care medical products, operating theater products, and patient care produ 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...
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FDA Code / Regulation: GEC / 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.
