Forceps Suppliers
Limit companies to: Worldwide USA
Grieshaber & Co. AG | Address: Winkelriedstr 52, Schaffhausen 8203, Switzerland
Phone: +41-(52)-632-3434
Employee Count: ~80 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Forceps Needle Holders, Stainless Steel Needle Holders, Tungsten Carbide Needle Holders, Micro Needle Holder, ...
Grieshaber & Co. AG specializes in offering ophthalmic surgical instruments. We offer iris retractors for use in surgical procedure on the eye of a living being. We also offer device for improving dra more...
Phone: +41-(52)-632-3434
Employee Count: ~80 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Forceps Needle Holders, Stainless Steel Needle Holders, Tungsten Carbide Needle Holders, Micro Needle Holder, ...
Grieshaber & Co. AG specializes in offering ophthalmic surgical instruments. We offer iris retractors for use in surgical procedure on the eye of a living being. We also offer device for improving dra more...
Ulrich Ag | Address: Movenstr 12, St. Gallen 9015, Switzerland
www.ulrich-swiss.ch | Send Inquiry | Phone: +41-(71)-314-6262
FDA Registration: 8039053 Employee Count: ~20 Quality: CE Certified
Products: Forceps (FDA Code: HTD), Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), Bulldog Clamps, Bulldog Clamps, Straight, Bulldog Clamps, Cross-action, ...
Ulrich Ag manufactures and distributes general & special surgical instruments and medical appliances. Our products include general & surgical instruments developed for surgeons. We offer servicing of more...
www.ulrich-swiss.ch | Send Inquiry | Phone: +41-(71)-314-6262
FDA Registration: 8039053 Employee Count: ~20 Quality: CE Certified
Products: Forceps (FDA Code: HTD), Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), Bulldog Clamps, Bulldog Clamps, Straight, Bulldog Clamps, Cross-action, ...
Ulrich Ag manufactures and distributes general & special surgical instruments and medical appliances. Our products include general & surgical instruments developed for surgeons. We offer servicing of more...
Zimmer Gmbh | Address: Sulzer Allee 8, Winterthur CH-8404, Switzerland
FDA Registration: 9613350
Products: Forceps (FDA Code: HTD), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Drill Bit (FDA Code: HTW), ...
Zimmer Gmbh designs and manufactures reconstructive spinal and dental implants, trauma and related orthopedic surgical products. We also offer joint replacement solutions for knee pain and hip pain, a more...
FDA Registration: 9613350
Products: Forceps (FDA Code: HTD), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Drill Bit (FDA Code: HTW), ...
Zimmer Gmbh designs and manufactures reconstructive spinal and dental implants, trauma and related orthopedic surgical products. We also offer joint replacement solutions for knee pain and hip pain, a more...
Cenova Innovation & Production Ab | Address: 4, Florettgatan, Mjolby 595 43, Sweden
www.cenova.se | Send Inquiry | Phone: +46-(142)-55800
FDA Registration: 3005216725
Products: Forceps (FDA Code: HTD), Needles, Anesthetics, Medical Needles, Prostate Cancer Treatment, Medication Nebulizers, ...
Cenova Innovation & Production Ab specializes in the production of plastic medical devices. Our product line comprises of ampoule cartridge, bone cement mixer, blister for implants, medication cup, mu more...
www.cenova.se | Send Inquiry | Phone: +46-(142)-55800
FDA Registration: 3005216725
Products: Forceps (FDA Code: HTD), Needles, Anesthetics, Medical Needles, Prostate Cancer Treatment, Medication Nebulizers, ...
Cenova Innovation & Production Ab specializes in the production of plastic medical devices. Our product line comprises of ampoule cartridge, bone cement mixer, blister for implants, medication cup, mu more...
Stille AB | Address: Sundbybergsvagen 1A, Solna SE-171 73, Sweden
www.stille.se | Send Inquiry | Phone: +46-(8)-588-580-00
FDA Registration: 3003696170 Year Established: 1841
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Rasps (FDA Code: HTR), Umbilical Artery Catheter (FDA Code: FOS), ...
Stille AB specializes in surgical instruments. We deal with surgical instruments, headlights, retractor systems and specialty tables. Our bariatric retractor systems provide the surgeon with maximum s more...
www.stille.se | Send Inquiry | Phone: +46-(8)-588-580-00
FDA Registration: 3003696170 Year Established: 1841
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Rasps (FDA Code: HTR), Umbilical Artery Catheter (FDA Code: FOS), ...
Stille AB specializes in surgical instruments. We deal with surgical instruments, headlights, retractor systems and specialty tables. Our bariatric retractor systems provide the surgeon with maximum s more...
Rumex Intl. Co. | Address: 2-102 Maly Peschany, Moskva 101000, Russian Federation
Phone: +7-(305)-591-2779
FDA Registration: 9681360
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Lacrimal Probes (FDA Code: HNL), Forceps Needle Holders, Stainless Steel Needle Holders, Tungsten Carbide Needle Holders, ...
Rumex Intl. Co. provides ophthalmic scissors, cannulae, specula, speculum, spatulae, fixation ring, knife, radial keratotomy and corneal marker. more...
Phone: +7-(305)-591-2779
FDA Registration: 9681360
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Lacrimal Probes (FDA Code: HNL), Forceps Needle Holders, Stainless Steel Needle Holders, Tungsten Carbide Needle Holders, ...
Rumex Intl. Co. provides ophthalmic scissors, cannulae, specula, speculum, spatulae, fixation ring, knife, radial keratotomy and corneal marker. more...
Tumbotino, M.Gorky Medical Instrument Plant(miz) | Address: 1 Pushkina Str., Tumbotino 606131, Russian Federation
www.tumbotino.ru | Send Inquiry | Phone: +7-(831)-716-8155
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Surgical Retractor Systems (FDA Code: GAD), Microsurgical Instruments (FDA Code: GZX), Bone Clamp (FDA Code: HXD), ...
Tumbotino, M.Gorky Medical Instrument Plant (miz) manufactures medical instruments for general surgery, cardiovascular surgery, pediatric surgery, neurosurgery, ophthalmology, otorhinolaryngology, obs more...
www.tumbotino.ru | Send Inquiry | Phone: +7-(831)-716-8155
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Surgical Retractor Systems (FDA Code: GAD), Microsurgical Instruments (FDA Code: GZX), Bone Clamp (FDA Code: HXD), ...
Tumbotino, M.Gorky Medical Instrument Plant (miz) manufactures medical instruments for general surgery, cardiovascular surgery, pediatric surgery, neurosurgery, ophthalmology, otorhinolaryngology, obs 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...
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...
Sur - Med | Address: 45-C, Aslam Arcade, Street No. 11, Badar Commercial Area, Phase-, D. H. A., Karachi 75500, Pakistan
www.sur-med-intl.com | Send Inquiry | Phone: +92-(52)-429-0671
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), ...
Sur-Med manufactures surgical and medical instruments. Our products include orthopedic implants, and instruments, anesthesia products, laryngoscopes sets, diagnostic equipments and products, general s more...
www.sur-med-intl.com | Send Inquiry | Phone: +92-(52)-429-0671
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), ...
Sur-Med manufactures surgical and medical instruments. Our products include orthopedic implants, and instruments, anesthesia products, laryngoscopes sets, diagnostic equipments and products, general s 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...
Chaplet Int. (Pvt.) Ltd. | Address: P.O.Box # 10039, Ferozepur Road, Lahore 54600, Pakistan
www.chapletint.com | Send Inquiry | Phone: +92-(42)-58222334
FDA Registration: 3003998824
Products: Clamps, Forceps (FDA Code: HTD), Catheter Trays, Bone Mallets (FDA Code: HXL), Stainless Steel Kidney Tray, Rib Rongeurs (FDA Code: HTX), ...
Chaplet Int. (Pvt.) Ltd. offers a comprehensive range of surgical holloware, hospital ware, surgical instruments handling and care products. Our product line comprises of wire net baskets, endoscope b more...
www.chapletint.com | Send Inquiry | Phone: +92-(42)-58222334
FDA Registration: 3003998824
Products: Clamps, Forceps (FDA Code: HTD), Catheter Trays, Bone Mallets (FDA Code: HXL), Stainless Steel Kidney Tray, Rib Rongeurs (FDA Code: HTX), ...
Chaplet Int. (Pvt.) Ltd. offers a comprehensive range of surgical holloware, hospital ware, surgical instruments handling and care products. Our product line comprises of wire net baskets, endoscope b more...
Electro Range MFG Co. | Address: Building 62-B Street 32 Ugoki Model Town Sialkot, Punjab 51310, Pakistan
www.electrorange.com | Send Inquiry | Phone: +92-(523)-514 381
Year Established: 1996 Annual Revenues: USD 10-25 Million Employee Count: ~50 Quality: ISO 9001:2008, ISO 13485, CE Mark Certified
Products: Gynecology Instruments, Forceps (FDA Code: HTD), Scissors, Hooks, Bipolar Forceps, Electrodes - Disposable, ...
Electro Range MFG Co.r provides a wide range of electrosurgical instruments. Our range of products includes bipolar/monopolar forceps, non-stick-irrigation bipolar forceps, bipolar/monopolar cables, E more...
www.electrorange.com | Send Inquiry | Phone: +92-(523)-514 381
Year Established: 1996 Annual Revenues: USD 10-25 Million Employee Count: ~50 Quality: ISO 9001:2008, ISO 13485, CE Mark Certified
Products: Gynecology Instruments, Forceps (FDA Code: HTD), Scissors, Hooks, Bipolar Forceps, Electrodes - Disposable, ...
Electro Range MFG Co.r provides a wide range of electrosurgical instruments. Our range of products includes bipolar/monopolar forceps, non-stick-irrigation bipolar forceps, bipolar/monopolar cables, E more...
Pamir Impex | Address: 7/84, Serwar Shaheed Road, Sialkot, Punjab 51310, Pakistan
www.pamirimpex.com | Send Inquiry | Phone: +92-(52)-4265649
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Scalpel Handle (FDA Code: GDZ), Mouth Gags (FDA Code: KBN), ...
Pamir Impex is a manufacturer and exporter of surgical & dental instruments. Our surgical instruments include diagnostic, bone surgery, ophthalmology, otology, cardiovascular and rhinology instruments more...
www.pamirimpex.com | Send Inquiry | Phone: +92-(52)-4265649
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Scalpel Handle (FDA Code: GDZ), Mouth Gags (FDA Code: KBN), ...
Pamir Impex is a manufacturer and exporter of surgical & dental instruments. Our surgical instruments include diagnostic, bone surgery, ophthalmology, otology, cardiovascular and rhinology 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...
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...
The Fazex Co. | Address: Po Gohadpur, Sialkot 22161, Pakistan
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Electronic Stethoscopes (FDA Code: DQD), Obstetrical Forceps (FDA Code: HDA), Forceps Needle Holders, Stainless Steel Needle Holders, ...
The Fazex Co. specializes in offering surgical and dental instruments. Our products include gastroenterologic needle holders, operating room table accessories, surgical hammers, scalpel handle, genera more...
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Electronic Stethoscopes (FDA Code: DQD), Obstetrical Forceps (FDA Code: HDA), Forceps Needle Holders, Stainless Steel Needle Holders, ...
The Fazex Co. specializes in offering surgical and dental instruments. Our products include gastroenterologic needle holders, operating room table accessories, surgical hammers, scalpel handle, genera more...
Stone Instruments Co. | Address: Commissioner Road, Muhammad Pura, Sialkot 51310, Pakistan
www.stone.com.pk | Send Inquiry | Phone: +92-(432)-588604
FDA Registration: 9614093 Quality: ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Forceps Needle Holders, Stainless Steel Needle Holders, Tungsten Carbide Needle Holders, ...
Stone Instruments Co. specializes in surgical and dental instruments. Our product list comprises of scissors, needle holders, retractors and scalpel blades. more...
www.stone.com.pk | Send Inquiry | Phone: +92-(432)-588604
FDA Registration: 9614093 Quality: ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Forceps Needle Holders, Stainless Steel Needle Holders, Tungsten Carbide Needle Holders, ...
Stone Instruments Co. specializes in surgical and dental instruments. Our product list comprises of scissors, needle holders, retractors and scalpel blades. more...
Instrumed (Pvt.) Ltd. | Address: 65-B, Small Industries Estate, P.O. Box. 51310, Sialkot, Pakistan
www.instrumed.com.pk | Send Inquiry | Phone: +92-(52)-3256589, 3559127
Year Established: 1982 Annual Revenues: USD 5-10 Million Quality: ISO-13485 , CE Certified
Products: Forceps (FDA Code: HTD), Dressing Forceps, Tissue Forceps, Suction Tubes, Gastroenterologic Needle Holder (FDA Code: FHQ), Calipers, ...
Instrumed (Pvt.) Ltd. manufactures surgical and dental instruments. We are an ISO 9001, ISO 13485, CE, cGMP and FDA certified company. Our surgical instruments include abdominal spatulas, abortion sco more...
www.instrumed.com.pk | Send Inquiry | Phone: +92-(52)-3256589, 3559127
Year Established: 1982 Annual Revenues: USD 5-10 Million Quality: ISO-13485 , CE Certified
Products: Forceps (FDA Code: HTD), Dressing Forceps, Tissue Forceps, Suction Tubes, Gastroenterologic Needle Holder (FDA Code: FHQ), Calipers, ...
Instrumed (Pvt.) Ltd. manufactures surgical and dental instruments. We are an ISO 9001, ISO 13485, CE, cGMP and FDA certified company. Our surgical instruments include abdominal spatulas, abortion sco more...
Bukhsh International | Address: P.O.Box No 2313, Sialkot 51310, Pakistan
www.bukhsh.com | Send Inquiry | Phone: +92-(52)-4264335
FDA Registration: 3003454257
Products: Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Tissue Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), ...
Bukhsh International offers surgical, dental, hair transplantation, and hollow ware products. We manufacture surgical instruments that are widely used in hospitals and surgery centers. We offer these more...
www.bukhsh.com | Send Inquiry | Phone: +92-(52)-4264335
FDA Registration: 3003454257
Products: Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Tissue Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), ...
Bukhsh International offers surgical, dental, hair transplantation, and hollow ware products. We manufacture surgical instruments that are widely used in hospitals and surgery centers. We offer these more...
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FDA Code / Regulation: HTD / 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.
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