Ascendia MedTech AB

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Contact: Jane Campbell
Web: http://www.amedic.se
E-Mail:
Address: Finlandsgatan 18, Kista S-164 74, Sweden
Phone: +46-(8)-4445400 | Fax: +46-(8)-6230972 | Map/Directions >>

Profile: Ascendia MedTech AB provides products that facilitate ultrasound procedures, improves safety and precision as well as the diagnostic quality of the tissue sample. The Amedic clip & pin needle guide system is a complete system for all major ultrasound machines. It has all the necessary components for abdominal needle procedures such as fine-needle or core biopsy, drainage aspiration, amniocentesis and catherization. The system accommodates six needle sizes, from 13 gauge (2.5 mm) to 22 gauge (0.7 mm). It features easy to use, high precision and quick needle release. Each kit contains 40 procedure kits and one adapter. Intracavity needle guide system is a disposable system for rectal/vaginal biopsy and puncture procedures. The system is designed to fit needle sizes from 16 gauge (1.6mm) to 22 gauge (0.7mm). Safe Scan protective covers are made of seamless elastic latex. They are specially designed for maximum flexibility and safety during intracavity examinations with ultrasound. Form-fitted for a snug fit over the transducer face, to ensure that no air bubbles can cause image artifacts. The seven different sizes of the protective covers are developed to fit intracavity transducers from various manufacturers. These are leak resistance tested and packaged in hygienic individually easy-to-tear foil packages.

The company is IS0 9001 certified.

FDA Registration Number: 8032029
US Agent: Jane B. Campbell / J.&d. Campbell Associates, Inc.
Phone: +1-(843)-314-3670 E-Mail:

14 Products/Services (Click for related suppliers)

• 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.

• Biopsy Instruments (FDA Code: KNW / 876.1075)

• Biopsy Needle Kit (FDA Code: FCG / 876.1075)

• Diagnostic Ultrasonic Transducer (FDA Code: ITX / 892.1570)

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

• Disposable Surgical Drape (FDA Code: KKX / 878.4370)

A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

• Electrosurgical Electrode Gel (FDA Code: JOT / 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.

• Instrument Surgical Guide (FDA Code: FZX / 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.

• Obstetric Ultrasonic Transducer (FDA Code: HGL / 884.2960)

An obstetric ultrasonic transducer is a device used to apply ultrasonic energy to, and to receive ultrasonic energy from, the body in conjunction with an obstetric monitor or imager. The device converts electrical signals into ultrasonic energy, and vice versa, by means of an assembly distinct from an ultrasonic generator. This generic type of device may include the following accessories: coupling gel, preamplifiers, amplifiers, signal conditioners with their power supply, connecting cables, and component parts. This generic type of device does not include devices used to generate the ultrasonic frequency electrical signals for application.

• Sterile Surgical Drapes (FDA Code: KKX / 878.4370)

• Support Gel Test (FDA Code: JZR / 866.4900)

A support gel for clinical use is a device that consists of an agar or agarose preparation that is used while measuring various kinds of, or parts of, protein molecules by various immunochemical techniques, such as immunoelectrophoresis, immunodiffusion, or chromatography.

• Surgical Drapes (FDA Code: KKX / 878.4370)

• Surgical Drapes & Packs (FDA Code: KKX / 878.4370)

• Urology Surgical Drapes (FDA Code: KKX / 878.4370)