FDA-Device2019-04-17Class II
Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures
Beaver Visitec
Hazard
Mislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, the marking on device shows a 2.75mm size device
Sold states
Worldwide Distribution - US Nationwide Foreign:UNITED KINGDOM JAPAN NETHERLANDS
Affected count
196 boxes (10units/box)
Manufactured in
500 Totten Pond Rd, 10 City Point, Waltham, MA, United States
Products
Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1111-2019Don't want to check this manually?
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