Product code
NTX: Nursing pad, polyurethane pad with starch copolymer, glycerin, and surfactant (f-68)
FDA product code · Class I · General Hospital
Key facts
| Product code | NTX |
|---|---|
| Device | Nursing pad, polyurethane pad with starch copolymer, glycerin, and surfactant (f-68) |
| Device class | Class I |
| Regulation number | 880.5630 |
| Review panel | General Hospital |
| Medical specialty | General Hospital |
| Submission type | 510(K) Exempt |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | A NURSING PAD CONSISTING OF A POLYURETHANE PAD WITH GLYCERIN USED TO RELIEVE NIPPLES THAT ARE SORE AND CRACKED FROM BREASTFEEDING. |
At a glance
- 1–9 510(k) clearances
- None 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