FDA-Device2023-08-02Class II
Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Single-pack UPN): M006L8406960
Boston Scientific Corporation
Hazard
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched
Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
231 units
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Single-pack UPN): M006L8406960
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2233-2023Don't want to check this manually?
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