HDE
BH991300: Orcel
FDA Humanitarian Device Exemption · Ortec International, Inc.
Key facts
| HDE number | BH991300 |
|---|---|
| Trade name | Orcel |
| Generic name | Pbd |
| Applicant | Ortec International, Inc. |
| Owner/operator | ORTEC Co., LTD. |
| Product code | PBD |
| Approval date | Feb 21, 2001 |
| Establishment registration | 3009119999 |
| FEI number | 3009119999 |
At a glance
- None Supplements
- Feb 21, 2001 Latest supplement decision
- No Summary of safety and probable benefit on file
- None UDI device identifiers (GUDID)
- None 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: