FDA-Device2018-02-07Class II
bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
Beaver-Visitec International Inc.
Hazard
The protective shield was retracted, and the blade was exposed.
Sold states
Worldwide Distribution - US Nationwide and the countries of Italy, UK, Finland, Germany, Ireland, Turkey
Affected count
45, 680 units
Manufactured in
411 Waverley Oaks Rd Ste 229, Waltham, MA, United States
Products
bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0500-2018Don't want to check this manually?
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