MicroAire SmartRelease Endoscopic System

  • 모델명 / 제조번호(시리얼번호)
    All products distributed from 1/1/13 to 2/23/18
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of: Australia, Belgium, Brazil, Canada, Chile, Czech Republic, Denmark, France, Germany, Hong Kong, India, Iran, Ireland, Israel, Italy, Jordan, Korea, Lebanon, Mexico, Nicaragua, Poland, Russia, Saudi Arabia, Serbia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UAE, and UK.
  • 제품 설명
    MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D || The MicroAire Carpal Tunnel Release System is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any other known pathology (i.e., idiopathic carpal tunnel syndrome). Preoperative x-rays of the wrist, including a carpal tunnel view, are recommended to aid in the diagnosis of associated pathology (i.e., calcific tendonitis, fracture of the hook of the hamate). This device is indicated for releasing the transverse carpal ligament (flexor retinaculum).
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    MicroAire Surgical Instruments, LLC, 3590 Grand Forks Blvd, Charlottesville VA 22911-9006
  • 제조사 모회사 (2017)
  • Source
    USFDA