Profile: Technimen Skillers is a manufacturer of air conduction hearing aids, blood collection lancets, general & plastic surgery forceps, ophthalmic headband mirrors, arm slings, ear suction tubes, scalpel handles, automatic surgical staplers, disposable medical scissors, general surgical scissors, nasal rasps, nasal scissors and wire twisters.

FDA Registration Number: 3001620590
US Agent: M Razi / Medix Instruments
Phone: +1-(201)-714-7003  Fax: +1-(201)-714-9550  E-Mail:

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• Air Conduction Hearing Aid (FDA Code: ESD / 874.3300) A hearing aid is wearable sound-amplifying device that is intended to compensate for impaired hearing. This generic type of device includes the air-conduction hearing aid and the bone-conduction hearing aid, but excludes the group hearing aid or group auditory trainer (874.3320), master hearing aid (874.3330), and tinnitus masker (874.3400).

• 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.

• Automatic Surgical Stapler (FDA Code: GAG / 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.

• Blood Collection Lancet (FDA Code: FMK / 878.4800)

• Bone Clamp (FDA Code: HXD / 878.4800)

• Disposable Medical Scissors (FDA Code: JOK / 880.6820) Medical disposable scissors are disposable type general cutting devices intended for medical purposes. This generic type of device does not include surgical scissors.

• Drill Bit (FDA Code: HTW / 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.

• Drill Handpiece (Brace) (FDA Code: HBD / 882.4325) A cranial drill handpiece (brace) is a hand holder, which is used without a power source, for drills, burrs, trephines, or other cutting tools that are used on a patient's skull.

• Ear Curette (FDA Code: JYG / 874.4420)

• Ear Excavator (FDA Code: JYH / 874.4420)

• Ear Scissors (FDA Code: JZB / 874.4420)

• 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.

• Ear Speculum Holder (FDA Code: JYK / 878.1800)

• Ear Suction Tube (FDA Code: JZF / 874.4420)

• Ear-Lobe Perforator (FDA Code: JYS / 874.4420)

• Elastic Bandages (FDA Code: FQM / 880.5075) An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.

• ENT Forceps (FDA Code: KAE / 874.4420)

• ENT Irrigation Syringe (FDA Code: KCP / 874.5220) An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.

• ENT Syringe (FDA Code: KCP / 874.5220)

• Forceps (FDA Code: HTD / 878.4800)

• 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 Forceps (FDA Code: GEN / 878.4800)

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

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

• Gynecological Biopsy Forceps (FDA Code: HFB / 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:

• Hand Splint and Component (FDA Code: ILH / 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.

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

• Hemostats (FDA Code: HRQ / 878.4800)

• 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)

• Manual Nebulizer Pump (FDA Code: EPN / 874.5220)

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

• Microsurgical Ear Hook (FDA Code: JYL / 874.4420)

• Middle Ear Chisel (FDA Code: JYE / 874.4420)

• Mouth Gags (FDA Code: KBN / 874.4420)

• Nasal Chisel (FDA Code: KAN / 878.4800)

• Nasal Curette (FDA Code: KAP / 874.4420)

• Nasal Dilator (FDA Code: LWF / 874.3900) A nasal dilator is a device intended to provide temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or transient causes of nasal congestion associated with reduced nasal airflow. The device decreases airway resistance and increases nasal airflow. The external nasal dilator is constructed from one or more layers of material upon which a spring material is attached, with a skin adhesive applied to adhere to the skin of the nose; it acts with a pulling action to open the nares. The internal nasal dilator is constructed from metal or plastic and is placed inside the nostrils; it acts by pushing the nostrils open or by gently pressing on the columella.

• Nasal Knife (FDA Code: KAS / 874.4420)

• Nasal Punch (FDA Code: KAY / 874.4420)

• Nasal Rasps (FDA Code: KBA / 874.4420)

• Nasal Rongeur (FDA Code: KBB / 874.4420)

• Nasal Saw (FDA Code: KBC / 874.4420)

• Nasal Scissors (FDA Code: KBD / 874.4420)

• Nasal Scissors Straight (FDA Code: KBD / 874.4420)

• Nasal Snare (FDA Code: KBE / 874.4420)

• Neurosurgical Head Rest (FDA Code: HBM / 882.4440) A neurosurgical headrest is a device used to support the patient's head during a surgical procedure.

• Non Dental Irrigating Syringe (FDA Code: KYZ / 880.6960) An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound.

• Non-Electric Biopsy Forceps (FDA Code: FCL / 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.