Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)
NYS is the FDA product code for Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac), a class II device type, regulated under 21 CFR 878.4015. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- NYS
- Device name
- Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)
- FDA 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.
- Regulation
- 21 CFR 878.4015
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code NYS
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2009 | 1 |
Applicants with the most clearances
Product code NYS| Applicant | Clearances |
|---|---|
| Quick-Med Technologies, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code NYS.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.