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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• AC-Powered Medical Examination Device (FDA Code: KZF / 880.6320) An AC-powered medical examination light is an AC-powered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.

• AC-Powered Radiofrequency Cautery Apparatus (FDA Code: HQR / 886.4100) A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.

• 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.

• Amniotome (FDA Code: HGE / 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:

• Angled Tongue Depressor

• Blood Collection Sets with Needle Holder

• Blood Needle Holder Systems

• Ceiling Mounted Surgical Light (FDA Code: FSY / 878.4580) A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

• Coronary Needle Holders

• Cosmetic Surgery, Needle Holder (Serrated)

• Cranioclast (FDA Code: HGA / 884.4500) An obstetric fetal destructive instrument is a device designed to crush or pull the fetal body to facilitate the delivery of a dead or anomalous (abnormal) fetus. This generic type of device includes the cleidoclast, cranioclast, craniotribe, and destructive hook.

• Crile Wood Needle Holder

• Culdoscopic Coagulator and Accessories (FDA Code: HFI / 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.

• Curved Carbide Jaw Needle Holder

• Dental Mouth Gag

• Detachable Needle Electrode Cables & Accessories

• Disposable Concentric Needle Electrodes

• Disposable Injectable Monopolar Needle Electrodes

• Disposable Monopolar Needle Electrodes

• Disposable Stimulating Needle Electrodes

• Disposable Subdermal EEG Needle Electrodes

• Disposable Subdermal Hooked Needle Electrodes

• Double Prong Skin Hooks

• Double Sharped Skin Hook

• Ear Scissors (FDA Code: JZB / 874.4420)

• Electrically Powered Saw (FDA Code: DWI / 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.

• Electrosurgical and Coagulation Unit with Accessories (FDA Code: BWA / 878.4400) An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

• Electrosurgical Apparatus (FDA Code: HAM / 878.4400)

• Electrosurgical Cutting and Coagulation Device (FDA Code: GEI / 878.4400)

• Electrosurgical Electrode (FDA Code: JOS / 878.4400)

• Endoscope Transformer (FDA Code: GCW / 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.

• ENT Forceps (FDA Code: KAE / 874.4420)

• ENT Retractor (FDA Code: KAL / 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:

• Extended Disposable Needle Electrode

• External Pelvimeter (FDA Code: HER / 884.4520)

• Flavored Tongue Depressors

• Forceps (FDA Code: HTD / 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.

• Forceps Needle Holders

• Gastro-Urology and Gastrointestinal Esophageal Bougie (FDA Code: FAT / 876.5365) An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).

• 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 Saw Surgical Blade (FDA Code: GFA / 878.4820)

• General & Plastic Surgery Forceps (FDA Code: GEN / 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 Spatula (FDA Code: GAF / 878.4800)

• Gillies Skin Hook

• Gynecological Surgical Forceps (FDA Code: HCZ / 884.4530)

• Hexagonal Needle Holder

• Infant Mouth Gag