MicroAire Surgical Instruments, LLC

9 devices in the database

  • Model / Serial
    All products distributed from 1/1/13 to 2/23/18
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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).
  • Model / Serial
    LIT 0317305390
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution.
  • Product Description
    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
  • Model / Serial
    Part Number, Lot Number, Quantity Distributed to Field 1600-9355NS, 61005, 56; 1600-9625NS, 60297, 209; 1604-162NS, 62856, 97.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    United States.
  • Product Description
    MicroAire K-Wires
  • Model / Serial
    Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The product was distributed in the United States and Sweden
  • Product Description
    Endotine Transbleph 3.5 (CFD-080-0167)
  • Model / Serial
    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
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    United States
  • Product Description
    Pneumatic Impactor, General Surgery, With Microaire Hose Connector || Professional Use, Medical Industry
4 more

3 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    MicroAire Surgical Instruments, LLC, 1641 Edlich Dr, Charlottesville VA 22911-5839
  • Manufacturer Parent Company (2017)
  • Source
    USFDA
  • Manufacturer Address
    MicroAire Surgical Instruments, LLC, 3590 Grand Forks Blvd, Charlottesville VA 22911-9001
  • Manufacturer Parent Company (2017)
  • Source
    USFDA