MicroAire Surgical Instruments, LLC

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 9 건

  • 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).
  • 모델명 / 제조번호(시리얼번호)
    LIT 0317305390
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Distribution.
  • 제품 설명
    SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE || This product line is intended for use in orthopaedic surgery (large and small bone surgeries) to cut bone
  • 모델명 / 제조번호(시리얼번호)
    Part Number, Lot Number, Quantity Distributed to Field 1600-9355NS, 61005, 56; 1600-9625NS, 60297, 209; 1604-162NS, 62856, 97.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    United States.
  • 제품 설명
    MicroAire K-Wires
  • 모델명 / 제조번호(시리얼번호)
    Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    The product was distributed in the United States and Sweden
  • 제품 설명
    Endotine Transbleph 3.5 (CFD-080-0167)
  • 모델명 / 제조번호(시리얼번호)
    2500-100 Ser#s 1547,1546,1545,1544, 1543,1542, 1541,1540,1539,1538,1537,1536,1535,1534,1533,1532  2500-200 Ser#s 1464,1463,1462,1461
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    United States
  • 제품 설명
    Pneumatic Impactor, General Surgery, With Microaire Hose Connector || Professional Use, Medical Industry
하나 더 4 건 더

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 3 건

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 주소
    MicroAire Surgical Instruments, LLC, 1641 Edlich Dr, Charlottesville VA 22911-5839
  • 제조사 모회사 (2017)
  • Source
    USFDA
  • 제조사 주소
    MicroAire Surgical Instruments, LLC, 3590 Grand Forks Blvd, Charlottesville VA 22911-9001
  • 제조사 모회사 (2017)
  • Source
    USFDA