Product code
NQB: Conformer, ophthalmic, biological tissue
FDA product code · Class II · Ophthalmic
Key facts
| Product code | NQB |
|---|---|
| Device | Conformer, ophthalmic, biological tissue |
| Device class | Class II |
| Regulation number | 886.3130 |
| Review panel | Ophthalmic |
| Medical specialty | Ophthalmic |
| Submission type | 510(K) Exempt |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | The ophthalmic conformer with molded plastic and biological tissue insert is introduced temporarily between the eyeball and eyelid to maintain space in the orbital cavity, prevent closure or adhesions during the healing process following surgery, and enables positioning of biological tissue to the ocular surface without the need for sutures. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- 1–9 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