Product code
PBY: Temporary tissue marker
FDA product code · Class II · General & Plastic Surgery
Key facts
| Product code | PBY |
|---|---|
| Device | Temporary tissue marker |
| Device class | Class II |
| Regulation number | 878.4300 |
| Review panel | General & Plastic Surgery |
| Medical specialty | General & Plastic Surgery |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | To temporarily (< 30 days) mark a tissue site intended for surgical removal. The tissue marker is surgically removed with the target tissue. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 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