Profile: Hammacher Instrumente Gmbh is a manufacturer of stainless steel wironit instruments for dental, biological and medical laboratories. Our dental products include impression trays, whetstones, surgical needles, elevators, finger protectors, implant instruments, rongeurs, bone rasps, lancets, needle holders and tweezers. We supply crown instruments, pliers, ceramic instruments, scalpels and scissors to dental laboratories. Our orthodontic products are micro blades, drug delivery systems, needle holders, osteometers, brushes, gags, sutures, sinus instruments and saws.

The company has revenues of < USD 1 Million, has ~30 employees and is ISO 9001, CE certified.

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• Absorbable Suture Anchors

• Absorbable Suture Screwed Anchor

• Absorbable Sutures (FDA Code: GAK / 878.4830) An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.

• Adenoid Curettes (FDA Code: KBJ / 874.4420)

• Adenoid Punches (FDA Code: KBS / 874.4420)

• 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.

• 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.

• Angled Tongue Depressor

• Angular Ear Curette

• Bending/Contouring Instrument (FDA Code: HXP / 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.

• Bio Absorbable Suture Anchors

• 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.

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

• Blood Collection Sets with Needle Holder

• Blood Lancet Needle (Blade Type)

• Blood Lancet Needle (Pen Type)

• Blood Lancets

• Blood Needle Holder Systems

• 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 Fixation Nail (FDA Code: JDS / 888.3030) Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

• Bone Fixation Plate (FDA Code: HRS / 888.3030)

• Bone Fixation Screw (FDA Code: HWC / 888.3040) A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

• Bone Rasps (FDA Code: HTR / 878.4800)

• Breathing Mouthpiece (FDA Code: BYP / 868.5620) A breathing mouthpiece is a rigid device that is inserted into a patient's mouth and that connects with diagnostic or therapeutic respiratory devices.

• Buck Ear Curettes

• Cardiovascular Surgical Instrument (FDA Code: DWS / 870.4500) Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.

• Cardiovascular Surgical Saw Blade (FDA Code: DWH / 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.

• Cardiovascular Trocar (FDA Code: DRC / 870.1390) A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.

• Catheter Dilator (FDA Code: GCC / 878.4200) An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

• Child Ear Curette

• Clip Removal Instrument (FDA Code: HBQ / 882.4200) A clip removal instrument is a device used to remove surgical clips from the patient.

• Clip Surgical Applier (FDA Code: GDO / 878.4800)

• Coronary Needle Holders

• Cosmetic Microsurgical Instruments

• Cosmetic Surgery, Needle Holder (Serrated)

• Crile Wood Needle Holder

• Crimp Pliers (FDA Code: FJY / 876.5540) A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.

• Curettes (FDA Code: HTF / 878.4800)

• Curved Carbide Jaw Needle Holder

• Dental Mouth Gag

• 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.

• Differential Ventilation Tracheal/Bronchial Tube (FDA Code: CBI / 868.5740) A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.

• Disconnect Forceps (FDA Code: FJR / 876.5540)

• Disposable Adenoid Curettes

• Disposable Blood Lancet Needles

• Disposable Ear Curette

• 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.

• Dissecting Scalpel Blades

• Dissecting Scalpel Handle

• Double Prong Skin Hooks