FDA-Device2020-12-16Class II
PROKERA Slim, non-sterile - Product Usage: Biologic corneal bandage.
TissueTech, Inc.
Hazard
Potential exposure of product to microbial contamination.
Sold states
US Nationwide distribution including in the states of FL, MN, NY, NC, SC, NJ, GA, PA, MD, DC, OH, WA, MI, CO, KS, TN, ME, AL, AR, TX, KY, MA, CA, CT, and OK.
Affected count
75 units
Manufactured in
8305 NW 27th St Ste 101, N/A, Doral, FL, United States
Products
PROKERA Slim, non-sterile - Product Usage: Biologic corneal bandage.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0552-2021Don't want to check this manually?
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