Profile: Josef Heiss Medizintechnik GmbH is a manufacturer of micro-surgical instruments. Our products include dressing forceps, needle holders, Luer lock syringes, eye shields, swab handles, iris scissors, dressing & tissue forceps, and optical center markers.

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• AC-Powered Operating Headlamp (FDA Code: HPQ / 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.

• Adenoid Curettes (FDA Code: KBJ / 874.4420)

• Angled Biopsy Punch

• Angular Ear Curette

• Antrum Perforator (FDA Code: KAT / 874.4420)

• Battery-Powered Ophthalmoscope (FDA Code: HLJ / 886.1570) An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.

• Biopsy Punch (FDA Code: FCI / 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.

• Biopsy Punch Forceps

• Biopsy Punch Tray

• Biopsy Punches (FDA Code: FCI / 876.1075)

• Blood Collection Sets with Needle Holder

• Blood Needle Holder Systems

• Bone Rasps (FDA Code: HTR / 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.

• Buck Ear Curettes

• Castroviejo Curved Ophthalmic Caliper

• Castroviejo Double Ended Lacrimal Dilator

• Castroviejo Straight Ophthalmic Caliper

• Cervical Biopsy Punch

• Cervical Cone Knife (FDA Code: HDZ / 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:

• Child Ear Curette

• Chisel/Osteotome (FDA Code: KDG / 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.

• Circular Dermal Biopsy Punch

• Corneo-Scleral Punch (FDA Code: HNJ / 886.4350) A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

• Coronary Needle Holders

• Cosmetic Surgery, Needle Holder (Serrated)

• Crile Wood Needle Holder

• Curettes (FDA Code: HTF / 878.4800)

• Curved Carbide Jaw Needle Holder

• Dental Protector (FDA Code: BRW / 868.5820) A dental protector is a device intended to protect a patient's teeth during manipulative procedures within a patient's oral cavity.

• Dermal Biopsy Punch (FDA Code: FCI / 876.1075)

• Diagnostic Condensing Lens (FDA Code: HJL / 886.1380) A diagnostic condensing lens is a device used in binocular indirect ophthalmoscopy (a procedure that produces an inverted or reversed direct magnified image of the eye) intended to focus reflected light from the fundus of the eye.

• Disposable Adenoid Curettes

• Disposable Biopsy Punch

• Disposable Biopsy Punches (FDA Code: FCI / 876.1075)

• Disposable Ear Curette

• Disposable Lacrimal Dilators

• Disposable Ophthalmic Cannulae

• Double Ended Lacrimal Dilator

• Double Ended Lacrimal Probe

• Double-Ended Disposable Ear Curettes

• Dressing and Tissue Forceps

• Ear Curette (FDA Code: JYG / 874.4420)

• Ear Knife (FDA Code: JYO / 874.4420)

• Ear Rasp (FDA Code: JYY / 874.4420)

• Ear Spoon (FDA Code: JZE / 874.4420)

• Ear Spoon & Hook

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

• Electric Drill Motor (FDA Code: HBC / 882.4360) An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.

• Elliptical Biopsy Punch

• Elliptical Biopsy Punches