PXQ · Burn Dressing Tray
General, Plastic Surgery · 21 CFR 878.4022 · Class 1
Overview
| Product Code | PXQ |
|---|---|
| Device Name | Burn Dressing Tray |
| Regulation | 21 CFR 878.4022 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A hydrogel wound dressing is a sterile or non-sterile device intended to cover a wound, to absorb wound exudate, to control bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination. It consists of a nonresorbable matrix made of hydrophilic polymers or other material in combination with water (at least 50 percent) and capable of absorbing exudate. This classification does not include a hydrogel wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
