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Address: 626 Cooper Court, Schaumburg, Illinois 60173, USA
www.instrumedinc.biz |
Phone: +1-(847)-908-0292
FDA Registration: 1421101
Products: Laparoscopic Equipment, Retractor System, General Surgical Instruments, Titanium Microsurgical Instruments, Orthopedic Instruments, Maxillofacial Prosthesis, ...
Instrumed International, Inc. specializes in providing reusable surgical instruments. We offer surgical products for bipolar, CV/thoracic, ENT, general, hand & micro surgery, laparoscopic, laryngeal,
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Address: New Bedford Industrial Park, New Bedford, Massachusetts 02745, USA
www.symmetrymedical.com |
Phone: +1-(508)-998-4493
Products: Calipers, Flexible Osteotome System, Bone Tamp, Orthopedic Caliper, Reamer (FDA Code:
HTO), Screw Removal Systems, ...
Symmetry Medical Inc. manufactures implants, instruments and cases to orthopedic devices. We offer cases and trays that made of metal, plastic or hybrid. We provide forged, cast, machined and finished
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Address: G-6 Gee Cee Crescent, 114, Ponamallee High Road, Chennai, Tamil Nadu 60084, India
www.gescoindia.com |
Send Inquiry |
Phone: +91-(44)-2825 96 02
FDA Registration: 9613926 Quality: ISO 9001:2000 Certified
Products: Small Depth Gauge (FDA Code:
HTJ), Depth Gauge (FDA Code:
HTJ), Y-Stent Forceps, Guiding Probes, Flexible Depth Gauge (FDA Code:
HTJ), ENT Forceps (FDA Code:
KAE), ...
General Surgical Co., (india) Pvt. Ltd. is a manufacturer of surgical instruments. We produce medical & surgical disposables, general, ENT, neuro & spinal, orthopedic, gynecology & obstetrics, plastic
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FDA Code / Regulation: NNN / 874.3540 A prosthesis modification instrument for ossicular replacement surgery is a device intended for use by a surgeon to construct ossicular replacements. This generic type of device includes the ear, nose, and throat cutting block; wire crimper, wire bending die; wire closure forceps; piston cutting jib; gelfoamTMpunch; wire cutting scissors; and ossicular finger vise.
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 874.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180 of this chapter, with respect to general requirements concerning records, and 820.198 of this chapter, with respect to complaint files.