Profile: Etablissements Boutmy S.A. specializes in offering disposable and implantable products. Our products include obstetric and gynecologic general manual instruments, tongue depressor, various needle holders, wire crimper, and gastroenterology-urology fiberoptic retractor.

FDA Registration Number: 9680837
US Agent: Judith E. O'grady / Integra Lifesciences Corporation
Phone: +1-(609)-936-2311  Fax: +1-(609)-275-9445  E-Mail:

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• Ruler and Caliper (FDA Code: FTY / 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.

• Saws (FDA Code: HSO / 878.4800)

• Scalpel Blade (FDA Code: GES / 878.4800)

• Scalpel Handle (FDA Code: GDZ / 878.4800)

• Self-Retaining Retractor Systems

• Self-Retaining Retractors (FDA Code: FFO / 876.4730) A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.

• Sensory Evaluation Tuning Fork

• Serrated Jaws Carbide Jaw Needle Holder

• Single Handed Scalpel Blade Remover

• Single use VacutainerT Needle Holder

• Single-Use Needle Holder

• Sinus Cannula (FDA Code: KAM / 878.4800)

• Sinus Endoscopy, Adenoid Curettes

• Sinus Endoscopy, Adenoid Punch

• Sinus Endoscopy, Antrum Punch

• Sinus Endoscopy, Ear Speculums

• Sinus Endoscopy, Ethmoid Punch

• Sinus Endoscopy, Mouth Gag

• Sinus Endoscopy, Nasal Scissors

• Sinus Endoscopy, Needle Holders

• Sinus Irrigator (FDA Code: KAR / 874.4420)

• Sinus Trephine (FDA Code: KBF / 874.4420)

• Sinus Trocar (FDA Code: KBG / 874.4420)

• Soft Ear Speculum (FDA Code: EPY / 878.1800) A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.

• Speculum Accessories (FDA Code: FXG / 878.1800)

• Spoon Ear Curette

• Stainless Steel Needle Holders

• Standard Needle Holders

• Staphylococcus Aureus Screening Kit (FDA Code: JWX / 866.2660) A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

• Sterile ENT Piston Cutting Jig (FDA Code: JXY / 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.

• Sterile ENT Wire Bending Die (FDA Code: JXW / 874.3540)

• Sterile ENT Wire Closure Forceps (FDA Code: JXX / 874.3540)

• Sterile ENT Wire Crimper (FDA Code: JXT / 874.3540)

• Sterile ENT Wire Cutting Scissors (FDA Code: JYA / 874.3540)

• Sterile Tongue Depressors

• Straight Carbide Jaw Needle Holder

• Straight Ear Curette

• Surgical Curette (FDA Code: FZS / 878.4800)

• Surgical Hammer (FDA Code: FZY / 878.4800)

• Surgical Metal Tongue Depressor (FDA Code: KBL / 874.4420)

• Surgical Needle Guide (FDA Code: GDF / 878.4800)

• Surgical Orthopedic Scissors (FDA Code: HRR / 888.4540) An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

• Surgical Punch (FDA Code: LRY / 878.4800)

• Surgical Retractor (FDA Code: GAD / 878.4800)

• Surgical Retractor Systems (FDA Code: GAD / 878.4800)

• Surgical Snare (FDA Code: GAE / 878.4800)

• Surgical Stripper (FDA Code: HRT / 888.4540)

• Surgical Stylet (FDA Code: GAH / 878.4800)

• Sweetened Tongue Depressors

• Titanium Beaver Scalpel Handle