Search Results
Found 1 results
510(k) Data Aggregation
K Number
DEN200063Device Name
Kerasave
Manufacturer
AL.CHI.MI.A. S.r.l
Date Cleared
2022-05-02
(578 days)
Product Code
QCW
Regulation Number
886.4320Why did this record match?
Search-Everything :
Matched: '886.4320'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Kerasave is indicated for storage of human corneas at 2-8°C for up to 14 days. It is intended for prescription (Rx) use by physicians or highly skilled personnel, such as Eye Bank operators.
Device Description
Kerasave is made of a buffered corneal storage medium, which provides basic nutrients for cell maintenance during storage of donor corneas at 2-8°C for up to 14 days, at physiological pH. The device also includes antimicrobial agents. The antibiotics are dissolved in the solution and an antifungal agent is formulated as a tablet for stability reason and constitutes integral part of the device; it shall be dissolved in the medium prior to use.
Ask a Question
Page 1 of 1