FDA-Device2015-06-24Class II
Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.
Amerx Health Care Corp.
Hazard
Nonapproved labeling claims (Sterile)
Sold states
Worldwide Distribution -- US, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY and Hawaii; and, the countries of Canada and Bahrain.
Affected count
6,491 units
Manufactured in
1300 S. Highland Avenue, Clearwater, FL, United States
Products
Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1797-2015Don't want to check this manually?
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