Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac

No FDA recalls found in the data synced 25 Oct 2026.

510(k) Number

K212320 ↗

FDA Product Code

OMP

Device Class

Class II

Regulation

21 CFR Part 878.4780

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• What is the Dermatac Drape with SensaT.R.A.C. NPWT Dressing used for?

  This device combines a draping system with granulated polyurethane foam dressings featuring SensaT.R.A.C. Technology to enhance wound healing. It applies controlled negative pressure to promote granulation tissue formation and reduce exudate, making it suitable for chronic or acute wounds—including those requiring debridement or infection control. The technology integrates with powered suction devices to maintain a therapeutic environment.

• How are the Dermatac Drape and V.A.C. Granufoam Dressings supplied, and are they reusable?

  The dressings are supplied in sterile, single-use packs only. Each pack contains either 5 or 10 dressings, available in three sizes: Small, Medium, and Large. Due to their sterile packaging and single-use design, they are not intended for reuse. Proper disposal follows single-use guidelines to ensure patient safety and infection control.

• What sizes and configurations are available for these dressings?

  The dressings come in three sizes—Small, Medium, and Large—and are packaged in two configurations: 5-pack or 10-pack. The sizing is designed to accommodate varying wound dimensions, ensuring appropriate coverage and negative pressure application for optimal healing outcomes.

• How should these dressings be stored to maintain sterility?

  To preserve sterility, the dressings must be stored according to the manufacturer’s instructions. This typically includes keeping them in their original, unopened packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. Avoid storing them in areas with high humidity or contamination risks, such as near surgical instruments or chemical agents.

• Are there any MRI safety considerations for this device?

  The provided device data does not specify any MRI safety information. If MRI compatibility is required for a patient, clinicians should verify compatibility with the specific model of the powered suction device used in conjunction with these dressings, as the dressings themselves do not appear to have MRI-related restrictions.