Product code
PFZ: Ophthalmic sealant
FDA product code · Class III · Ophthalmic
Key facts
| Product code | PFZ |
|---|---|
| Device | Ophthalmic sealant |
| Device class | Class III |
| Review panel | Ophthalmic |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | An ophthalmic sealant is intended to maintain an incision closure and aid in preventing fluid egress from incisions in the eye. |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 1–9 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database