Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)
General, Plastic Surgery · 21 CFR 878.4015
Open FDA's page for this record- Third party flag
- N
- Life sustain support flag
- N
- Gmp exempt flag
- N
- Summary malfunction reporting
- Ineligible
- Product code
- NYS
- Review panel
- SU
- Medical specialty
- SU
- Device name
- Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)
- Medical specialty description
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4015
- Implant flag
- N
- Submission type ID
- 1
- Definition
A wound dressing with poly (diallyl dimethyl ammonium chloride) (pdadmac) additive is a device that is a sterile barrier wound dressing intended for use as a primary dressing for exuding wounds, first and second degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing. The device consists of a textile substrate and permanently bound pdadmac. The device acts as a physical barrier to outside contaminants and does not act on the surface or interior of the wound nor does it contain antimicrobial agents that act on the body.
- Harmonized identifiers (openFDA)
- K number
- DEN070002
