Product code
OWP: Biological sterilization process indicator with recombinant-dna plasmid
FDA product code · Class II · General Hospital
Key facts
| Product code | OWP |
|---|---|
| Device | Biological sterilization process indicator with recombinant-dna plasmid |
| Device class | Class II |
| Regulation number | 880.2805 |
| Review panel | General Hospital |
| Medical specialty | General Hospital |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | A Recombinant-DNA plasmid biological indicator is intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. |
At a glance
- 1–9 510(k) clearances
- 1–9 De Novo grants
- None 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