FDA-Device2018-05-23Class II
Trident Endoscopic Ultrasonic Biopsy Needle (FNB)
Micro-Tech (Nanjing) Co., Ltd.
Hazard
The combination of the firmness of the mass, the potential endoscope and elevator position combined with the force required to penetrate the mass may contribute to the breakage of the needle in the human body, which could cause injury.
Sold states
US distribution to one distributor in MI.
Affected count
40 total
Manufactured in
High Tech, NO. 10 Gaoke Third Road Nanjing National, Nanjing, China
Products
Trident Endoscopic Ultrasonic Biopsy Needle (FNB)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1877-2018Don't want to check this manually?
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