FDA-Device2021-01-20Class II
EXOGEN Ultrasound Coupling Gel
Bioventus, LLC
Hazard
Product may contain white particulates that are microbial in nature.
Sold states
United States (Nationwide), Australia, Austria, Belgium, Canada, Cyprus, Denmark, France, Germany, Hong Kong, Ireland, Italy, Japan, Netherlands, Norway, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom
Affected count
115,584 units
Manufactured in
1900 Charles Bryan Rd Ste 275, N/A, Cordova, TN, United States
Products
EXOGEN Ultrasound Coupling Gel
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0810-2021Don't want to check this manually?
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