FDA-Device2023-03-08Class II
CustomEyes kits
Beaver Visitec International, Inc.
Hazard
Device packaging may contain open seals, compromising product sterility.
Sold states
US distribution in AL, CA, CO, DC, FL, GA, IL, LA, MD, MN, MT, NC, NH, NJ, NM, NY, OH OK, PA, RI, TN, TX, UT, VA, VT, WA, and WI OUS distribution to Canada, Japan, and South Africa
Affected count
4640 units in total
Manufactured in
500 Totten Pond Rd, 10 City Point, Waltham, MA, United States
Products
CustomEyes kits
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1200-2023Don't want to check this manually?
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