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Address: Saint Aubin Le Monial, Rue Le Pavillon, Bourbon L Archambault 03160, France
Phone: +33-(70)-67-0451
FDA Registration: 9680837
Products: Nasal Rasps (FDA Code:
KBA), Adjustable Frequency Tuning Fork, Hertz Frequency Tuning Fork, Sensory Evaluation Tuning Fork, Aluminium Tuning Fork, Magnesium Tuning Forks, ...
Etablissements Boutmy S.A. specializes in offering disposable and implantable products. Our products include obstetric and gynecologic general manual instruments, tongue depressor, various needle hold
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Address: 9250 Avenue Du Parc, Suite 514, Montreal, Quebec H2N 1Z2, Canada
www.coroneo.com |
Send Inquiry |
Phone: +1-(514)-3369230
FDA Registration: 9616227 Year Established: 1997
Quality: ISO 13485:2003 Certified
Products: Surgical Retractor Systems (FDA Code:
GAD), Cardiovascular Surgical Instrument (FDA Code:
DWS), Surgical Snare (FDA Code:
GAE), Surgical Retractor (FDA Code:
GAD), ...
Coroneo, Inc. specializes in the research, development, and product commercialization of medical devices in the field of cardiac surgery. The extra-aortic annuloplasty ring, supports dystrophic aortic
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Address: 1273 St. -Louis St, B.P. 120, Terrebonne, Quebec J6W 3L5, Canada
www.handstable.com |
Send Inquiry |
Phone: +1-(450)-471-1379, 800-361-1502
FDA Registration: 9615857 Year Established: 1997
Quality: ISO 9002 Certified
Products: Ophthalmic Caliper (FDA Code:
HOE), Soft Ear Speculum (FDA Code:
EPY), Ear Speculum (FDA Code:
EPY), Manual Corneal Burr (FDA Code:
HOF), Ear Suction Tube (FDA Code:
JZF), Surgical Knife (FDA Code:
EMF), ...
Instrumentarium specializes in ENT surgical instruments. Our product line includes otology, stapes and middle fossa instruments. Our otology instruments include straight vertical scissors, 3 mm blades
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Address: Rue De La Glacerie 6/21, FraniA"re 5150, Belgium
www.sibelsa.be |
Phone: 328-145-0459
Products: Wire Twisters (FDA Code:
HXS), Automatic Wire Twisters, Surgical Instruments, Wire Twisters, Sternal Wire Twister, Disposable Electrosurgical Snare, Surgical Snare (FDA Code:
GAE), ...
Simal Sa is a manufacturer of surgical instruments. Our products include micro scissors, tissue forceps, hemostatic forceps, clamping forceps, flat and round handle micro needle holders, bulldog & vas
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Address: Im Letten 1, Feldkirch 6800, Austria
www.ami.at |
Send Inquiry |
Phone: +43-(5522)-905050
FDA Registration: 3005049530
Products: Surgical Snare (FDA Code:
GAE), General & Plastic Surgery Laparoscope (FDA Code:
GCJ), Polyglycolic Acid Synthetic Absorbable Suture (FDA Code:
GAM), Surgical Cutter (FDA Code:
FZT), Ultrasonic Pulsed Doppler Imaging System (FDA Code:
IYN), Endoscopic Cleaning Accessories (FDA Code:
FEB), ...
Agency For Medical Innovations Gmbh deals with surgical products. Our products are surgical snare, ultrasonic pulsed doppler imaging system and surgical cutter.
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FDA Code / Regulation: GAE / 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.