Product code
REN: Particle-size measuring instrument
FDA product code · Not Classified
Key facts
| Product code | REN |
|---|---|
| Device | Particle-size measuring instrument |
| Device class | Not Classified |
| GMP exempt | Yes |
| Definition | Product, laser, instrument, particle size measurement; An instrument or system incorporating a laser for determining the size or number of particles of particles a test sample. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- None MAUDE adverse event reports
- 1–9 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