Product code
PUV: Lymph node location system during sentinel biopsy procedure
FDA product code · Class III · General & Plastic Surgery
Key facts
| Product code | PUV |
|---|---|
| Device | Lymph node location system during sentinel biopsy procedure |
| Device class | Class III |
| Review panel | General & Plastic Surgery |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | Locating lymph nodes draining a tumor as part of the sentinel lymph node biopsy procedure |
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