FDA-Device2021-05-26Class II
10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD
BIOPSYBELL S.R.L.
Hazard
Products labeled as sterile were distributed, but may not have been sterilized.
Sold states
US Nationwide distribution in the states MS and KY.
Affected count
625 units
Manufactured in
Via Aldo Manuzio N. 24, Via A.Manuzio n.24, Mirandola, N/A, Italy
Products
10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1637-2021Don't want to check this manually?
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