QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING
Device Facts
| Record ID | DEN070002 |
|---|---|
| Device Name | QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING |
| Applicant | Quick-Med Technologies, Inc. |
| Product Code | NYS · General, Plastic Surgery |
| Decision Date | Feb 25, 2009 |
| Decision | DENG |
| Submission Type | Post-NSE |
| Regulation | 21 CFR 878.4015 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A wound dressing with pDADMAC additive is intended for use as a primary dressing for exuding wounds, 1st and 2d degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing.
Special Controls
*Classification.* Class II (special controls). The special control is: the FDA guidance document entitled “Class II Special Controls Guidance Document: Wound Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) (pDADMAC) Additive.” See § 878.1(e) for availability of this guidance document.
