MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS
Device Facts
| Record ID | K901853 |
|---|---|
| Device Name | MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS |
| Applicant | Johnson & Johnson Medical, Inc. |
| Product Code | NAD · General, Plastic Surgery |
| Decision Date | Jan 28, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4020 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing. This classification does not include an occlusive 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.
