Product code
PZU: Bone marrow processing device for clinical use
FDA product code · Not Classified · Hematology
Key facts
| Product code | PZU |
|---|---|
| Device | Bone marrow processing device for clinical use |
| Device class | Not Classified |
| Review panel | Hematology |
| Submission type | Contact ODE |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Preparation of concentrated bone marrow aspirate (cBMA) from a sample of bone marrow for clinical use |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None 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