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General Surgical Co., (india) Pvt. Ltd.

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Web: http://www.gescoindia.com
E-Mail:
Address: G-6 Gee Cee Crescent, 114, Ponamallee High Road, Chennai, Tamil Nadu 60084, India
Phone: +91-(44)-2825 96 02 | Fax: +91-(44)-2825 94 39 | Map/Directions >>
 
 

Profile: 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, cardio thoracic, urology, oncology, vascular, ophthalmic, dental, oral & maxillofacial surgery instruments.

The company is ISO 9001:2000 certified.

FDA Registration Number: 9613926
US Agent: David Lennarz / Registrar Corp
Phone: +1-(757)-224-0177  Fax: +1-(757)-224-0179  E-Mail:

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• AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE / 878.4820)
Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
• AC-Powered Operating Room Table (FDA Code: FQO / 878.4960)
Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.
• AC-Powered Surgical Chair (FDA Code: GBB / 878.4960)
• AC-Powered Surgical Instrument Motor (FDA Code: GEY / 878.4820)
• AC-Powered Surgical With Orthopedic Accessories Table (FDA Code: JEA / 878.4960)
• Adenoid Curettes (FDA Code: KBJ / 874.4420)
• Adenoid Punches (FDA Code: KBS / 874.4420)
• Adenotomes (FDA Code: KBH / 874.4420)
• Adjustable Hospital AC-Powered Beds (FDA Code: FNL / 880.5100)
An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.
• Adjustable Hospital Hydraulic Bed (FDA Code: FNK / 880.5110)
A hydraulic adjustable hospital bed is a device intended for medical purposes that consists of a bed with a hydraulic mechanism operated by an attendant to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.
• Adjustable Operating Room Stool (FDA Code: FZM / 878.4950)
A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.
• Adult 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.
• Aerosol Adhesive Drape (FDA Code: KGT / 878.4380)
A drape adhesive is a device intended to be placed on the skin to attach a surgical drape.
• Amniotome (FDA Code: HGE / 884.4530)
An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:
• Amputation Knife (FDA Code: GDN / 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.
• Anesthesia Stool (FDA Code: BRX / 868.6700)
An anesthesia stool is a device intended for use as a stool for the anesthesiologist in the operating room.
• Anesthesia Table and Tray Cabinet (FDA Code: BRY / 868.6100)
An anesthetic cabinet, table, or tray is a device intended to store anesthetic equipment and drugs. The device is usually constructed to eliminate build-up of static electrical charges.
• Antrum Perforator (FDA Code: KAT / 874.4420)
• Antrum Punch (FDA Code: KAW / 874.4420)
• Arm Slings (FDA Code: ILI / 890.3640)
An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
• Arm Supports (FDA Code: IOY / 890.3475)
A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.
• Arthroscopic Accessories (FDA Code: NBH / 888.1100)
An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.
• Attic Punch (FDA Code: JYX / 874.4420)
• Automatic Surgical Stapler (FDA Code: GAG / 878.4800)
• Battery Powered Ophthalmic Instrument Stand (FDA Code: NOI / 886.1860)
An ophthalmic instrument stand is an AC-powered or nonpowered device intended to store ophthalmic instruments in a readily accessible position.
• Battery-Operated Operating Headlamp (FDA Code: HPP / 886.4335)
An operating headlamp is an AC-powered or battery-powered device intended to be worn on the user's head to provide a light source to aid visualization during surgical, diagnostic, or therapeutic procedures.
• Battery-Powered Target Tangent Screen (FDA Code: HLK / 886.1810)
A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square cloth chart with a central mark of fixation intended to map on a flat surface the central 30 degrees of a patient's visual field. This generic type of device includes projection tangent screens, target tangent screens and targets, felt tangent screens, and stereo campimeters.
• Bed Board (FDA Code: FPS / 880.6070)
A bed board is a device intended for medical purposes that consists of a stiff board used to increase the firmness of a bed.
• Bender (FDA Code: HXW / 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.
• Bending/Contouring Instrument (FDA Code: HXP / 888.4540)
• Biofeedback Device (FDA Code: HCC / 882.5050)
A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.
• Biologic Eyelid Spacer/Graft Prosthesis (FDA Code: NXM / 886.3130)
An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery. ]
• Biopsy Forceps Cover (FDA Code: FFF / 876.1075)
A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
• Bladder Neck Spreader (FDA Code: FHK / 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.
• Bone Cap (FDA Code: JDT / 888.3000)
A bone cap is a mushroom-shaped device intended to be implanted made of either silicone elastomer or ultra-high molecular weight polyethylene. It is used to cover the severed end of a long bone, such as the humerus or tibia, to control bone overgrowth in juvenile amputees.
• Bone Clamp (FDA Code: HXD / 878.4800)
• Bone Hooks (FDA Code: KIK / 878.4800)
• Bone Mallets (FDA Code: HXL / 878.4800)
• Bone Mill (FDA Code: LYS / 888.4540)
• Bone Particle Collector (FDA Code: MXP / 874.4800)
A bone particle collector is a filtering device intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
• Bone Rasps (FDA Code: HTR / 878.4800)
• Bone Screw Starter (FDA Code: HWD / 888.4540)
• Bone Skid (FDA Code: HWO / 888.4540)
• Bone Staple Driver (FDA Code: HXJ / 888.4540)
• Bone Taps (FDA Code: HWX / 888.4540)
• Bone Trephine (FDA Code: HWK / 888.4540)
• Brace Setting Twister (FDA Code: ITO / 890.3410)
An external limb orthotic component is a device intended for medical purposes for use in conjunction with an orthosis (brace) to increase the function of the orthosis for a patient's particular needs. Examples of external limb orthotic components include the following: A brace-setting twister and an external brace stirrup.
• Broach (FDA Code: HTQ / 888.4540)
• Bronchial Cannulae (FDA Code: KCE / 878.4800)
• Cables (FDA Code: ISN / 890.3420)
An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.

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