Device classification

Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)

General, Plastic Surgery · 21 CFR 878.4015

Class IIProduct code NYS
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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
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.