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# Hemostatic Gauze Placed in Class 2
- URL: https://www.fdaweb.com/hemostatic-gauze-placed-in-class-2/
- Published: 2018-02-15T12:00:00.000Z
- Updated: 2026-09-14T23:22:58.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140771

*Federal Register* notice: FDA has classified non-absorbable, hemostatic gauze for temporary internal use into Class 2 (special controls). The action responds to a 2016 *de novo* classification request by Z-Medica for its D2 Dressing. The agency has identified the generic prescription device as intended to be placed temporarily for control of severely bleeding wounds such as surgical wounds and traumatic injuries. The gauze is coated or impregnated with a hemostatic material which may enhance hemostasis by physical means. It is intended to be removed once the patient is stabilized. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-02-15/pdf/2018-03135.pdf?ref=fdaweb.com).