Product code
QCZ: Mechanical and enzymatic autologous skin processor for cell suspension, with applicator
FDA product code · Class III · Hematology
Key facts
| Product code | QCZ |
|---|---|
| Device | Mechanical and enzymatic autologous skin processor for cell suspension, with applicator |
| Device class | Class III |
| Review panel | Hematology |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | Yes |
| Definition | Intended to enable clinicians to prepare an autologous skin cell suspension for application to burn injuries for use when autografting is indicated for definitive wound closure. |
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