General Surgical Manual Instrument Suppliers
Limit companies to: Worldwide USA
Stengelin Medical Gmbh | Address: Am Kirchenweg 5, Tuttlingen 78532, Germany 
www.stengelin.de | Send Inquiry | Phone: +49-(7461)-3233
FDA Registration: 9611278 Quality: ISO 14971 Certified
Products: General Surgical Instruments, Instruments surgical, Common Surgical Instrument, Surgical Retractor Systems (FDA Code: GAD), Specialty Surgical Instruments, Single Use Surgical Instruments, ...
Stengelin Medical Gmbh specializes in exporting surgical instruments. We also specialize in the development and manufacture of dental instruments. We develop and produce specially designed products to more...
www.stengelin.de | Send Inquiry | Phone: +49-(7461)-3233
FDA Registration: 9611278 Quality: ISO 14971 Certified
Products: General Surgical Instruments, Instruments surgical, Common Surgical Instrument, Surgical Retractor Systems (FDA Code: GAD), Specialty Surgical Instruments, Single Use Surgical Instruments, ...
Stengelin Medical Gmbh specializes in exporting surgical instruments. We also specialize in the development and manufacture of dental instruments. We develop and produce specially designed products to more...
HEBUmedical GmbH | Address: Badstrasse 8, Tuttlingen D-78532, Germany
www.hebumedical.de | Send Inquiry | Phone: +49-(7461)-94 710
FDA Registration: 9611112
Products: Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), Surgical Retractor Systems (FDA Code: GAD), ...
HEBUmedical GmbH specializes in the research, development, design and production of medical equipments. We are continuously engaged with the rationalization of new manufacturing sequences as well as t more...
www.hebumedical.de | Send Inquiry | Phone: +49-(7461)-94 710
FDA Registration: 9611112
Products: Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), Surgical Retractor Systems (FDA Code: GAD), ...
HEBUmedical GmbH specializes in the research, development, design and production of medical equipments. We are continuously engaged with the rationalization of new manufacturing sequences as well as t more...
Dewimed Medizintechnik GmbH | Address: Honbergstraße 1, Tuttlingen D-78532, Germany
www.dewimed.de | Send Inquiry | Phone: +49-(7461)-93340
FDA Registration: 3000286616 Quality: ISO 9001, ISO 13485 Certified
Products: Surgical Retractor Systems (FDA Code: GAD), Cardiovascular Surgical Instrument (FDA Code: DWS), General use Surgical Curettes (FDA Code: FZS), Surgical Snare (FDA Code: GAE), Surgical Retractor (FDA Code: GAD), Surgical Curette (FDA Code: FZS), ...
Dewimed Medizintechnik GmbH is a manufacturer of surgical instruments. We also offer dental products and equipments. We manufacture various surgical products for neurosurgery, gynecology, microsurgery more...
www.dewimed.de | Send Inquiry | Phone: +49-(7461)-93340
FDA Registration: 3000286616 Quality: ISO 9001, ISO 13485 Certified
Products: Surgical Retractor Systems (FDA Code: GAD), Cardiovascular Surgical Instrument (FDA Code: DWS), General use Surgical Curettes (FDA Code: FZS), Surgical Snare (FDA Code: GAE), Surgical Retractor (FDA Code: GAD), Surgical Curette (FDA Code: FZS), ...
Dewimed Medizintechnik GmbH is a manufacturer of surgical instruments. We also offer dental products and equipments. We manufacture various surgical products for neurosurgery, gynecology, microsurgery more...
RfQ-Medizintechnik GmbH & Co. KG | Address: Bruderhofstraße 10-12, Tuttlingen D-78532, Germany
www.rfq.de | Send Inquiry | Phone: +49-(7461)-9617-0
FDA Registration: 3004838841
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Hooks (FDA Code: KIK), Wire Cutters (FDA Code: HXZ), Microsurgical Instruments (FDA Code: GZX), Tonsil Dissector (FDA Code: KBM), ...
RfQ-Medizintechnik GmbH & Co. KG is a manufacturer and distributor of surgical instruments & equipments. We offer a wide range of medical products, surgical instruments, endoscopy products, devices an more...
www.rfq.de | Send Inquiry | Phone: +49-(7461)-9617-0
FDA Registration: 3004838841
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Hooks (FDA Code: KIK), Wire Cutters (FDA Code: HXZ), Microsurgical Instruments (FDA Code: GZX), Tonsil Dissector (FDA Code: KBM), ...
RfQ-Medizintechnik GmbH & Co. KG is a manufacturer and distributor of surgical instruments & equipments. We offer a wide range of medical products, surgical instruments, endoscopy products, devices an more...
Normed Gmbh | Address: Ulrichstr. 7, Tuttlingen 78532, Germany
www.normed-online.com | Send Inquiry | Phone: +49-(7461)-9343-0
Quality: CE mark 0123 ISO 13485 : 2003 and DIN EN 46001 Certified
Products: Wire Twisters (FDA Code: HXS), Tongue Depressors (FDA Code: FMA), Mouth Gags (FDA Code: KBN), Wire Cutters (FDA Code: HXZ), Stainless Steel Surgical Wire, Rib Rongeurs (FDA Code: HTX), ...
Normed Gmbh is a manufacturer of medical devices. We offer orthopedic, hand, neuro, foot or ankle, cranio-maxillo-facial surgery and ascension products. Our external fixator modular systems cover all more...
www.normed-online.com | Send Inquiry | Phone: +49-(7461)-9343-0
Quality: CE mark 0123 ISO 13485 : 2003 and DIN EN 46001 Certified
Products: Wire Twisters (FDA Code: HXS), Tongue Depressors (FDA Code: FMA), Mouth Gags (FDA Code: KBN), Wire Cutters (FDA Code: HXZ), Stainless Steel Surgical Wire, Rib Rongeurs (FDA Code: HTX), ...
Normed Gmbh is a manufacturer of medical devices. We offer orthopedic, hand, neuro, foot or ankle, cranio-maxillo-facial surgery and ascension products. Our external fixator modular systems cover all more...
Instrumed GmbH | Address: 3 Unter Buchsteig, Tuttlingen 78532, Germany
Phone: +49-(7462)-20049-126
FDA Registration: 8010372 Employee Count: ~10
Products: Vaginal Retractors (FDA Code: HDL), 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), ...
Instrumed GmbH deals with vaginal retractors, self-retaining retractors, ophthalmic rings, ronguers, ENT knives and hemostats. more...
Phone: +49-(7462)-20049-126
FDA Registration: 8010372 Employee Count: ~10
Products: Vaginal Retractors (FDA Code: HDL), 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), ...
Instrumed GmbH deals with vaginal retractors, self-retaining retractors, ophthalmic rings, ronguers, ENT knives and hemostats. more...
Rudolf Manz KG | Address: Ehrenbergstr. 45-47, Tuttlingen 78532, Germany
Phone: +49-(7461)-9601-0
FDA Registration: 8010775
Products: Orthopedic Implant, K Nail Measuring Gauge, Measuring Gauge (FDA Code: JYJ), General Surgical Manual Instrument (FDA Code: MDM), Removable Skin Clip (FDA Code: FZQ), ...
Rudolf Manz KG offers Boley gauges. Our Boley gauge is a caliper used for measuring the size of teeth in dentistry. more...
Phone: +49-(7461)-9601-0
FDA Registration: 8010775
Products: Orthopedic Implant, K Nail Measuring Gauge, Measuring Gauge (FDA Code: JYJ), General Surgical Manual Instrument (FDA Code: MDM), Removable Skin Clip (FDA Code: FZQ), ...
Rudolf Manz KG offers Boley gauges. Our Boley gauge is a caliper used for measuring the size of teeth in dentistry. more...
Aesculap Ag | Address: 1120, Tuttlingen, Donau D-78532, Germany
www.aesculap.de | Send Inquiry | Phone: +94-(610)-9849074
FDA Registration: 9610612
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), ...
Aesculap Ag offers instruments for minimal invasive surgery. Our product range includes surgical instruments for open or minimally invasive approaches, implants for orthopedic, neuro and spinal surger more...
www.aesculap.de | Send Inquiry | Phone: +94-(610)-9849074
FDA Registration: 9610612
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), ...
Aesculap Ag offers instruments for minimal invasive surgery. Our product range includes surgical instruments for open or minimally invasive approaches, implants for orthopedic, neuro and spinal surger more...
Rotec GmbH | Address: Am Muehlberg 31, Weisendorf 91085, Germany
Send Inquiry | Phone: +49-(9135)-3215
Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: ISO 9001, CE Certified
Products: General Surgical Manual Instrument (FDA Code: MDM), Durable Product Contract Manufacturing, ...
Rotec GmbH specializes in general surgical manual instruments. We also specialize in durable product contract manufacturing. more...
Send Inquiry | Phone: +49-(9135)-3215
Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: ISO 9001, CE Certified
Products: General Surgical Manual Instrument (FDA Code: MDM), Durable Product Contract Manufacturing, ...
Rotec GmbH specializes in general surgical manual instruments. We also specialize in durable product contract manufacturing. more...
Guenter Stoffel Medizintechnik Gmbh | Address: Kantstr. 37, Wurmlingen D-78573, Germany
www.insto.de | Send Inquiry | Phone: +49-(7461)-5890
FDA Registration: 8010370 Quality: ISO 13485, CE mark Certified
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Microsurgical Instruments (FDA Code: GZX), Bone Clamp (FDA Code: HXD), Cardiovascular Surgical Instrument (FDA Code: DWS), ENT Forceps (FDA Code: KAE), Surgical Instrument Tray (FDA Code: FSM), ...
Guenter Stoffel Medizintechnik Gmbh offers instruments for micro-surgery and endoscopy. Our product line includes biopsy forceps, scissors, tweezers, needle & blade holders, flexible endoscopy biopsy more...
www.insto.de | Send Inquiry | Phone: +49-(7461)-5890
FDA Registration: 8010370 Quality: ISO 13485, CE mark Certified
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Microsurgical Instruments (FDA Code: GZX), Bone Clamp (FDA Code: HXD), Cardiovascular Surgical Instrument (FDA Code: DWS), ENT Forceps (FDA Code: KAE), Surgical Instrument Tray (FDA Code: FSM), ...
Guenter Stoffel Medizintechnik Gmbh offers instruments for micro-surgery and endoscopy. Our product line includes biopsy forceps, scissors, tweezers, needle & blade holders, flexible endoscopy biopsy more...
Allsurg Medizintechnik UG | Address: Bachstr 8,, County Is Tuttlingen, Wurmlingen 78573, Germany
Phone: +49-(7461)-9107211
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Hooks (FDA Code: KIK), Tongue Depressors (FDA Code: FMA), ...
Allsurg Medizintechnik UG provides medical supplies. more...
Phone: +49-(7461)-9107211
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Hooks (FDA Code: KIK), Tongue Depressors (FDA Code: FMA), ...
Allsurg Medizintechnik UG provides medical supplies. more...
Trouamed Hengstler Gmbh | Address: Donaustr 2 A, Geisingen, Baden 78187, Germany
Phone: +49-(7704)-92440
FDA Registration: 8043746 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Self-Retaining Retractors (FDA Code: FFO), Arthroscopes (FDA Code: HRX), Surgical Retractor Systems (FDA Code: GAD), Laser Power Probe, ...
Trouamed Hengstler Gmbh is a manufacturer of general surgical manual instruments, hysteroscope accessories, laparoscopic electro surgery instruments, probes and surgical retractors. more...
Phone: +49-(7704)-92440
FDA Registration: 8043746 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Self-Retaining Retractors (FDA Code: FFO), Arthroscopes (FDA Code: HRX), Surgical Retractor Systems (FDA Code: GAD), Laser Power Probe, ...
Trouamed Hengstler Gmbh is a manufacturer of general surgical manual instruments, hysteroscope accessories, laparoscopic electro surgery instruments, probes and surgical retractors. more...
Vomed Volzer Medizintechnik GmbH & Co. KG | Address: In Gohren 25, Tuttlingen, Baden-Württemberg 78532, Germany
www.vomed.de | Send Inquiry | Phone: +49-(7461)-96570-0
Employee Count: ~30 Quality: CE Certified
Products: Forceps (FDA Code: HTD), Suction Tubes, Biopsy Forceps, Grasping Forceps, Standard Urethral Access, Irrigation Sets & Tubing, ...
Vomed Volzer Medizintechnik GmbH & Co. KG are medical-technology manufacturers of metal stopcocks, tube connectors, special cannulae and endoscopic accessories. Our products include accessories for en more...
www.vomed.de | Send Inquiry | Phone: +49-(7461)-96570-0
Employee Count: ~30 Quality: CE Certified
Products: Forceps (FDA Code: HTD), Suction Tubes, Biopsy Forceps, Grasping Forceps, Standard Urethral Access, Irrigation Sets & Tubing, ...
Vomed Volzer Medizintechnik GmbH & Co. KG are medical-technology manufacturers of metal stopcocks, tube connectors, special cannulae and endoscopic accessories. Our products include accessories for en more...
Ilumark GmbH | Address: Bodmerstrasse 11, Feldkirchen, Munchen, Bavaria 85622, Germany
www.ilumark.com | Send Inquiry | Phone: +49-(89)-90779598-0
Products: General Surgical Instruments, Instruments surgical, General Surgical Manual Instrument (FDA Code: MDM), ...
Ilumark GmbH specializes in sterile, retro-reflective single-use markers for image-guided surgery systems. Our Ilumark™ navigation markers are used to support surgical procedures in neurosurgery more...
www.ilumark.com | Send Inquiry | Phone: +49-(89)-90779598-0
Products: General Surgical Instruments, Instruments surgical, General Surgical Manual Instrument (FDA Code: MDM), ...
Ilumark GmbH specializes in sterile, retro-reflective single-use markers for image-guided surgery systems. Our Ilumark™ navigation markers are used to support surgical procedures in neurosurgery more...
Tontarra Medizintechnik Gmbh | Address: Daimlerstrasse 15, Wurmlingen, DE-BW D-78573, Germany
FDA Registration: 9680515
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), Surgical Retractor Systems (FDA Code: GAD), Lacrimal Dilator (FDA Code: HNW), Scalpel Handle (FDA Code: GDZ), ...
Tontarra Medizintechnik Gmbh is a provider of surgical instruments. more...
FDA Registration: 9680515
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), Surgical Retractor Systems (FDA Code: GAD), Lacrimal Dilator (FDA Code: HNW), Scalpel Handle (FDA Code: GDZ), ...
Tontarra Medizintechnik Gmbh is a provider of surgical instruments. more...
CM Instrumente GmbH | Address: Im Gänsäcker 56, Tuttlingen, Deutschland 78532, Germany
www.cm-instrumente.de | Send Inquiry | Phone: +49-(7462)-2042070
FDA Registration: 9680518
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), ...
Cm Instrumente Gmbh is a manufacturer and distributor of surgical instruments & surgical implants. Our surgical instruments include osteosynthesis, aluminum rib spreaders, atraumatic cardiovascular cl more...
www.cm-instrumente.de | Send Inquiry | Phone: +49-(7462)-2042070
FDA Registration: 9680518
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), ...
Cm Instrumente Gmbh is a manufacturer and distributor of surgical instruments & surgical implants. Our surgical instruments include osteosynthesis, aluminum rib spreaders, atraumatic cardiovascular cl more...
Kapp Surgical GmbH | Address: Hauptstr 5, Duerbheim, Kr Tuttlingen 78589, Germany
www.kapp-germany.de | Send Inquiry | Phone: +49-(7424)-94-03-0
FDA Registration: 8010769 Year Established: 1982 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Wire Twisters (FDA Code: HXS), Automatic Wire Twisters, Surgical Instruments, Wire Twisters, Sternal Wire Twister, Nasal Scissors Straight (FDA Code: KBD), ...
Kapp Surgical GmbH offers surgical products such as laminectomy rongeurs, intervertebral ronguers, jaws, bone rongeurs, bone cutting forceps, and wire cutting pliers. more...
www.kapp-germany.de | Send Inquiry | Phone: +49-(7424)-94-03-0
FDA Registration: 8010769 Year Established: 1982 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Wire Twisters (FDA Code: HXS), Automatic Wire Twisters, Surgical Instruments, Wire Twisters, Sternal Wire Twister, Nasal Scissors Straight (FDA Code: KBD), ...
Kapp Surgical GmbH offers surgical products such as laminectomy rongeurs, intervertebral ronguers, jaws, bone rongeurs, bone cutting forceps, and wire cutting pliers. more...
Hermann Medizintechnik GmbH | Address: Wurttemberger Straße 26, Fridingen, Kreis Tuttlingen 78567, Germany
www.hermann-medizintechnik.de | Send Inquiry | Phone: +49-(7463)-9967-0
FDA Registration: 8010257 Employee Count: ~40 Quality: ISO 9001, CE Certified
Products: Curettes, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Retractors, Scissors, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Hermann Medizintechnik GmbH manufactures surgical instruments, implants and equipment. Our product line comprises of titanium implant systems, laparoscopy, arthroscopy, electrosurgery, endoscopic unit more...
www.hermann-medizintechnik.de | Send Inquiry | Phone: +49-(7463)-9967-0
FDA Registration: 8010257 Employee Count: ~40 Quality: ISO 9001, CE Certified
Products: Curettes, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Retractors, Scissors, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Hermann Medizintechnik GmbH manufactures surgical instruments, implants and equipment. Our product line comprises of titanium implant systems, laparoscopy, arthroscopy, electrosurgery, endoscopic unit more...
Geister Medizintechnik GmbH | Address: Föhrenstrasse 2, Tuttlingen D-78532, Germany
www.geister.com | Send Inquiry | Phone: +49-(7461)-966240
FDA Registration: 8010697 Quality: DIN ISO 9001, ISO 13485 Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), ...
Geister Medizintechnik GmbH is a manufacturer of specialized surgical products carrying a full range of advanced surgical instruments and devices. We work in the three business fields such as cardio, more...
www.geister.com | Send Inquiry | Phone: +49-(7461)-966240
FDA Registration: 8010697 Quality: DIN ISO 9001, ISO 13485 Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), ...
Geister Medizintechnik GmbH is a manufacturer of specialized surgical products carrying a full range of advanced surgical instruments and devices. We work in the three business fields such as cardio, more...
Jakoubek | Address: Auf der Höhe 15, Liptingen, Tuttlingen D-78576, Germany
www.jakoubek.com | Send Inquiry | Phone: +49-(7465)-9264-0
FDA Registration: 9612277
Products: Probes (FDA Code: HXB), Bipolar Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), Arthroscopes (FDA Code: HRX), Surgical Retractor Systems (FDA Code: GAD), Reusable Bipolar Forceps, ...
Jakoubek supplies advanced surgical equipment. Our flexible gastro-intestinal product line comprises of biopsy forceps, probes, catheter and stone removal forceps. Our laparoscopy product line compris more...
www.jakoubek.com | Send Inquiry | Phone: +49-(7465)-9264-0
FDA Registration: 9612277
Products: Probes (FDA Code: HXB), Bipolar Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), Arthroscopes (FDA Code: HRX), Surgical Retractor Systems (FDA Code: GAD), Reusable Bipolar Forceps, ...
Jakoubek supplies advanced surgical equipment. Our flexible gastro-intestinal product line comprises of biopsy forceps, probes, catheter and stone removal forceps. Our laparoscopy product line compris more...
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FDA Code / Regulation: MDM / 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.
