Product code
LEM: Human lyophilized dura mater
FDA product code · Class II · Neurology
Key facts
| Product code | LEM |
|---|---|
| Device | Human lyophilized dura mater |
| Device class | Class II |
| Regulation number | 882.5975 |
| Review panel | Neurology |
| Medical specialty | Neurology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | Cber review required - previously regulated as a device under 21 cfr 882.5975, now regulated in cber under section 361 as banked human tissue. See definition at §1271.3(d). Subject to donor eligibility, good tissue practice, registration and listing requirements under part 1271" the good tissue practice regulation http://www.Fda.Gov/cber/rules/gtp.Pdf became final effective may 25, 2005. It states… |
At a glance
- 1–9 510(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