FDA-Device2023-05-03Class II
Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula.
Mani, Inc. - Kiyohara Facility
Hazard
A packaging defect may compromise the sterile barrier.
Sold states
Distribution in US - 1 consignee in Missouri
Affected count
45 kits
Manufactured in
Park 8-3, Kiyoharakogyodanchi; Kiyoharakogyodanchi; Kiyoharakogyodanchi, Utsunomiya, N/A, Japan
Products
Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1468-2023Don't want to check this manually?
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