Profile: Tontarra Medizintechnik Gmbh is a provider of surgical instruments.
FDA Registration Number: 9680515
US Agent: Dagmar Maeser / Business Support International
Phone: +1-(212)-331-8358 Fax: +1-(212)-257-6441 E-Mail:
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• 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. |
• 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. |
• 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. |
• Cystotome (FDA Code: HNY / 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. |
• Dermatomes (FDA Code: GFD / 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. |
• Diagnostic/Surgical Loupe (FDA Code: FSP / 878.4800) |
• 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 Brace (FDA Code: HXY / 888.4540) |
• Ear Scissors (FDA Code: JZB / 874.4420) |
• Electrically Powered Saw (FDA Code: DWI / 878.4820) |
• ENT Applicator (FDA Code: KCJ / 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 Forceps (FDA Code: KAE / 874.4420) |
• ENT Knife (FDA Code: KTG / 874.4420) |
• ENT Probe (FDA Code: KAK / 874.4420) |
• ENT Trocar (FDA Code: KTE / 874.4420) |
• Episiotomy Scissors (FDA Code: HDK / 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: |
• Fixed Size Cervical Dilator (FDA Code: HDQ / 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: |
• Gallstone Scoop (FDA Code: FHL / 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. |
• Gastro-Urology Probe and Director (FDA Code: FGM / 876.4730) |
• Gastro-Urology Trocar (FDA Code: FBQ / 876.5090) A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar. |
• Gastroenterologic Needle Holder (FDA Code: FHQ / 876.4730) |
• General & Plastic Surgery Forceps (FDA Code: GEN / 878.4800) |
• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. |
• 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 Hook (FDA Code: GDG / 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) |
• General Surgical Manual Instrument (FDA Code: MDM / 878.4800) |
• General Surgical Scissors (FDA Code: LRW / 878.4800) |
• General use Surgical Curettes (FDA Code: FZS / 878.4800) |
• Gynecological Biopsy Forceps (FDA Code: HFB / 884.4530) |
• Hemostats (FDA Code: HRQ / 878.4800) |
• Injection Cannula (FDA Code: FGY / 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. |
• Lacrimal Dilator (FDA Code: HNW / 886.4350) |
• Lacrimal Probes (FDA Code: HNL / 886.4350) |
• 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 Gastro-Urology Surgical Instrument (FDA Code: KOA / 876.4730) |
• Manual Rongeur (FDA Code: HAE / 882.4840) A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column. |
• Manual Saw & Accessories (FDA Code: GDR / 878.4800) |
• Manual Stethoscope (FDA Code: LDE / 870.1875) A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. |
• Manual Surgical Chisel (FDA Code: FZO / 878.4800) |
• Mastoid Rongeurs (FDA Code: JZA / 874.4420) |