Profile: Astra Tech Ab is a manufacturer of health care devices and dental implants.
The company has revenues of USD 100-500 Million, has ~600 employees and is ISO 9001, CE certified. NYSE:AAB (SEC Filings)
FDA Registration Number: 9612468
US Agent: Helen Lewis / Dentsply Sirona
Phone: +1-(717)-487-1332 Fax: +1-(717)-849-4343 E-Mail:
17 Products/Services (Click for related suppliers)
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• Closed Wound Drainage Kit |
• Disposable Surgical Instrument Kit (FDA Code: KDD / 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. |
• Disposable Vein Stripper (FDA Code: GAJ / 878.4800) |
• Foley Anchor-Urinary Catheter |
• Metal/Plastic Urethral Sound (FDA Code: FBX / 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. |
• Miniature Ultrasonic Surgical Aspirator |
• Rectal Catheter for Continent Ileostomy (FDA Code: KPH / 876.5030) A continent ileostomy catheter is a flexible tubular device used as a form during surgery for continent ileostomy and it provides drainage after surgery. Additionally, the device may be inserted periodically by the patient for routine care to empty the ileal pouch. This generic type of device includes the rectal catheter for continent ileostomy. |
• Sterile Closed Urine Drainage System for Nonindwelling Catheter (FDA Code: EYZ / 876.5250) A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are: |
• Surgical Aspirator |
• Surgical Aspirator Tips |
• Surgical Urethral Catheter (FDA Code: GBM / 876.5130) A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use). |
• Ultrasonic Surgical Aspirator |
• Urethral Catheters (FDA Code: GBM / 876.5130) |
• Urinary Catheters |
• Urinary Catheters & Kit |
• Uroflowmeter (FDA Code: EXY / 876.1800) A urine flow or volume measuring system is a device that measures directly or indirectly the volume or flow of urine from a patient, either during the course of normal urination or while the patient is catheterized. The device may include a drip chamber to reduce the risk of retrograde bacterial contamination of the bladder and a transducer and electrical signal conditioning and display equipment. This generic type of device includes the electrical urinometer, mechanical urinometer, nonelectric urinometer, disposable nonelectric urine flow rate measuring device, and uroflowmeter. |
• Urological Catheters (FDA Code: KOD / 876.5130) |