UNIFLEX
Device Facts
| Record ID | K820470 |
|---|---|
| Device Name | UNIFLEX |
| Applicant | Howmedica Corp. |
| Product Code | NAB · General, Plastic Surgery |
| Decision Date | Jun 2, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4014 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. This classification does not include a nonresorbable gauze/sponge for external use that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.
