FDA-Device2025-07-02Class I
MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.
Integra LifeSciences Corp. (NeuroSciences)
Hazard
Lack of sterility assurance.
Sold states
Worldwide distribution - US Nationwide and the countries of Taiwan (Province of China), Viet Nam, Brazil, Trinidad and Tobago, El Salvador, South Korea, Peru, Canada, Australia, New Zealand, Belgium, France, Germany, Ireland, Israel, Italy, Kenya, Slovenia, South Africa, Spain, Sweden, Switzerland and United Kingdom.
Affected count
4,882 units
Manufactured in
1100 Campus Rd, Princeton, NJ, United States
Products
MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1961-2025Don't want to check this manually?
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