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 Code | QCW |
Premarket Review |
Ophthalmic Devices
(DHT1A)
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 |