HDE
BH990200: Epicel
FDA Humanitarian Device Exemption · Vericel Corporation
Key facts
| HDE number | BH990200 |
|---|---|
| Trade name | Epicel |
| Generic name | Oce |
| Applicant | Vericel Corporation |
| Owner/operator | Vericel |
| Product code | OCE |
| Approval date | Oct 25, 2007 |
| Establishment registration | 1226230 |
| FEI number | 3002836339 |
At a glance
- None Supplements
- Oct 25, 2007 Latest supplement decision
- No Summary of safety and probable benefit on file
- 1–9 UDI device identifiers (GUDID)
- 1–9 MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: