Profile: Idea-Instrumentefabrik Berchtold & Co. GmbH specializes in the manufacture and export of medical & dental instruments. Our products include dental impression trays, hemostats, uterine dilators, dental excavators, hook forceps, surgical instruments with carbide insert, catheter sets, button probes, laryngoscopes, dental matrices, mouth mirror, matrix retainers, ear forceps and general scalpels.

The company has ~40 employees and is ISO 9002, CE certified.

FDA Registration Number: 8010153
US Agent: Jenny Harris / Stryker Communications
Phone: +1-(469)-470-4316  E-Mail:

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• Screwdriver (FDA Code: HXX / 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.

• Self-Retaining Retractor Systems

• Self-Retaining Retractors (FDA Code: FFO / 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.

• Serrated Jaws Carbide Jaw Needle Holder

• Sharpening Kit for Reusable Needle Electrodes

• Shortwave Diathermy for use in Applying Therapeutic Deep Heat (FDA Code: IMJ / 890.5290) A shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the radio frequency bands of 13 megahertz to 27.12 megahertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

• Single Prong Skin Hooks

• Single use VacutainerT Needle Holder

• Single-Use Needle Holder

• Sinus Endoscopy, Mouth Gag

• Sinus Endoscopy, Nasal Scissors

• Sinus Endoscopy, Needle Holders

• Skin Hook Forceps

• Skin Hooklet

• Skin hooks

• Stainless Steel Needle Holders

• Standard Needle Holders

• Sterile ENT Wire Cutting Scissors (FDA Code: JYA / 874.3540) A prosthesis modification instrument for ossicular replacement surgery is a device intended for use by a surgeon to construct ossicular replacements. This generic type of device includes the ear, nose, and throat cutting block; wire crimper, wire bending die; wire closure forceps; piston cutting jib; gelfoamTMpunch; wire cutting scissors; and ossicular finger vise.

• Sterile Tongue Depressors

• Straight Carbide Jaw Needle Holder

• Surgical Metal Tongue Depressor (FDA Code: KBL / 874.4420)

• Surgical Orthopedic Scissors (FDA Code: HRR / 888.4540)

• Surgical Pliers (FDA Code: HTC / 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.

• Surgical Retractor (FDA Code: GAD / 878.4800)

• Surgical Retractor Systems (FDA Code: GAD / 878.4800)

• Surgical Television Camera without Audio (FDA Code: FWB / 878.4160) A surgical camera and accessories is a device intended to be used to record operative procedures.

• Sweetened Tongue Depressors

• Table Operating Room Accessories (FDA Code: FWZ / 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.

• Titanium Needle Holders

• Tongue Depressor Holders

• Tongue Depressors (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.

• Triangle Needle Holder

• Tube Introduction Forceps (FDA Code: BWB / 868.5780) Tube introduction forceps (e.g., Magill forceps) are a right-angled device used to grasp a tracheal tube and place it in a patient's trachea.

• Tungsten Carbide Needle Holders

• Twisted Disposable Subdermal Needle Electrodes

• Umbilical Scissors (FDA Code: HDJ / 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:

• Unipolar Laparoscopic Coagulator (FDA Code: HFG / 884.4160) A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.

• Urological Bougie (FDA Code: FAX / 876.5520) A urethral dilator is a device that consists of a slender hollow or solid instrument made of metal, plastic, or other suitable material in a cylindrical form and in a range of sizes and flexibilities. The device may include a mechanism to expand the portion of the device in the urethra and indicate the degree of expansion on a dial. It is used to dilate the urethra. This generic type of device includes the mechanical urethral dilator, urological bougies, metal or plastic urethral sound, urethrometer, filiform, and filiform follower.

• Used Tongue Depressors

• Vaginal Dilators (FDA Code: HDX / 884.3900) A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery.

• Vaginal Retractors (FDA Code: HDL / 884.4520)

• Vascular Needle Holder

• Vertical Needle Holder

• Wire Cutters (FDA Code: HXZ / 888.4540)

• Wire Holding Forceps (FDA Code: HYA / 878.4800)

• Wooden Tongue Depressor

• Y-Stent Forceps