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U.S. Department of Health and Human Services

Product Classification
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Device corneal storage media with preservatives including anti-fungal
Definition Media to preserve human corneas while in storage.
Physical State Hypothermic solution with color-based pH indicator
Technical Method Immersion of corneal tissue in media that inhibits the growth of microbials while providing sufficient nutrients to maintain viability.
Target Area Eyes
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeQCW
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.4320
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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