VITRAX SODIUM HYALURONATE
Device Facts
| Record ID | P880031 |
|---|---|
| Device Name | VITRAX SODIUM HYALURONATE |
| Applicant | Abbott Medical Optics, Inc. |
| Product Code | LZP · Ophthalmic |
| Decision Date | Aug 10, 1989 |
| Decision | APWD |
| Regulation | 21 CFR 886.4275 |
| Device Class | Class 3 |
Regulatory Classification
Identification
An intraocular fluid is a device consisting of a nongaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.