Product InformationTechnical Information
The NanoFx instruments consist of a reusable Hand Instrument, a single use disposable PleuriStik Guide Wire, and a reusable Thumb Tab Accessory.
These instruments are used to perform a Nanofracture technique for the treatment of articular cartilage defects or where bone marrow stimulation is appropriate.
SHELF-LIFE
The sterile, single-use PleuriStiks have a shelf-life of 5 Years from date of manufacture.
TRANSPORTATION AND STORAGE
Keep at ambient temperature
MANUFACTURER
Arthrosurface Inc
28 Forge Parkway
Franklin, MA 02038, USA
REGULATORY STATUS
CE marked medical devices (MDD 93/42/EEC 2007/47/EC):
Class I – Reusable instruments
Class IIa – Single-use PleuriStik Guide Wire
FDA – Class I device, no 510(k)-clearance required. FDA Product Code: LXH
HOW SUPPLIED
5500-1020 Hand Instrument (Box 1)
FURS-2101 PleuriStik Guide Wire (Box 5)
5500-4010 A-Curve Hand Instrument (Box 1)
FURS-4101 PleuriStik Guide Wire (Box 5)
FURS-010R Thumb Tab Accessory (Box 1)
STERILITY
The NanoFx Hand Instruments and Thumb Tab Accessories are provided NON-STERILE.
They must be properly cleaned and sterilized before each use inspected for signs of wear or damage.
The NanoFx PleuriStik Guide Wires are provided STERILE-SINGLE-USE via exposure to gamma radiation
