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510(k) Data Aggregation
K Number
K063304Device Name
LIFE4C
Manufacturer
NUMEDIS, INC.
Date Cleared
2007-12-21
(415 days)
Product Code
LYX
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
NUMEDIS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LIFE4°C is indicated for storage of human corneas suitable for keratoplasty up to 14 days under refrigeration (2-8°C).
Device Description
Life49C is sterile, non-pyrogenic, advanced buffered corneal preservation medium which is supplemented with chondroitin sulfate (membrane stabilizer), recombinant human insulin (cell metabolism enhancer), Dextran (osmotic agent), glutathione (antioxidant, free-radical scavenger, enzyme cofactor), stabilized L-glutamine , ATP precursors, nutrient cell supplements, amino acids, vitamins, trace elements, gentamycin, streptomycin and phenol red (pH indicator).
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