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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• ENT Tracheal Hook (FDA Code: KCH / 874.4420)

• ENT Trocar (FDA Code: KTE / 874.4420)

• Ethmoid Curettes (FDA Code: KAO / 874.4420)

• Ethmoid Punch (FDA Code: KAX / 874.4420)

• Fiberoptic Retractor (FDA Code: FDG / 876.4530) A gastroenterology-urology fiberoptic retractor is a device that consists of a mechanical retractor with a fiberoptic light system that is used to illuminate deep surgical sites.

• Flat Wire Loop Retriever

• Flavored Tongue Depressors

• Forceps (FDA Code: 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.

• Forceps Needle Holders

• Frontal-Sinus Rasp (FDA Code: KAZ / 874.4420)

• Gastroenterologic Needle Holder (FDA Code: FHQ / 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.

• General & Plastic Surgery Biopsy Brush (FDA Code: GEE / 878.4800)

• General & Plastic Surgery Forceps (FDA Code: GEN / 878.4800)

• General & Plastic Surgery Mirror (FDA Code: FTX / 878.4800)

• General & Plastic Surgery Surgical Cannula (FDA Code: GEA / 878.4800)

• General & Plastic Surgery Surgical Clamp (FDA Code: GDJ / 878.4800)

• General & Plastic Surgery Surgical Dissector (FDA Code: GDI / 878.4800)

• General & Plastic Surgery Surgical Elevator (FDA Code: GEG / 878.4800)

• General & Plastic Surgery Surgical File (FDA Code: GEO / 878.4800)

• General & Plastic Surgery Surgical Gouge (FDA Code: GDH / 878.4800)

• General & Plastic Surgery Surgical Hook (FDA Code: GDG / 878.4800)

• General & Plastic Surgery Surgical Mallet (FDA Code: GFJ / 878.4800)

• General & Plastic Surgery Surgical Rasp (FDA Code: GAC / 878.4800)

• General & Plastic Surgery Surgical Spatula (FDA Code: GAF / 878.4800)

• General Manual Obstetric/Gynecologic Instrument (FDA Code: KOH / 884.4520) An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:

• General Surgical Scissors (FDA Code: LRW / 878.4800)

• General use Surgical Curettes (FDA Code: FZS / 878.4800)

• Hemostatic Clip Applier (FDA Code: HBT / 878.4800)

• Hertz Frequency Tuning Fork

• Hexagonal Needle Holder

• Illuminated Speculum (FDA Code: FXF / 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.

• Infant Mouth Gag

• Infant Tongue Depressor (FDA Code: FMA / 880.6230) A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues.

• Instrument Surgical Guide (FDA Code: FZX / 878.4800)

• Junior Tongue Depressor (FDA Code: FMA / 880.6230)

• Knee Self-Retaining Retractors

• Laryngeal Injection Kit (FDA Code: KAA / 874.4420)

• Laryngeal Knife (FDA Code: JZY / 874.4420)

• Laryngeal Trocar (FDA Code: KAB / 874.4420)

• Left Hand Needle Holders

• Ligature Carrier (FDA Code: GEJ / 878.4800)

• Ligature Carrier Set (FDA Code: GEJ / 878.4800)

• Ligature Passing and Knot Tying Instrument (FDA Code: HCF / 878.4800)

• Lighted Ear Curettes

• Magnesium Tuning Forks

• Manual Dermabrasion Brush (FDA Code: GED / 878.4800)

• Manual Osteotome (FDA Code: GFI / 878.4800)

• Manual Retractor

• Manual Saw & Accessories (FDA Code: GDR / 878.4800)

• Manual Surgical Chisel (FDA Code: FZO / 878.4800)