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HSA · registration DE0508418

KCI V.A.C. DERMATAC™ DRAPE

SingaporeGeneral & Plastic SurgeryClass BKCI USA, Inc.
Official record identity
Registration number
DE0508418
Model name
V.A.C. DERMATAC DRAPE
Model identifier
DTAC10LDP
Registration date
August 21, 2023
Classification
Risk class
Class B
Official value: CLASS B
Published category
General & Plastic Surgery
Published parties
Product owner
KCI USA, Inc.
Registrant / registration holder
KCI MEDICAL ASIA PTE. LTD.
Official description

The V.A.C. DERMATAC Drape is an accessory to specific integrated wound management systems. When used on open wounds, they are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts. When used on closed surgical incisions, they are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

Additional source fields
Product owner address
12930 IH 10 West, San Antonio, TX 78249, United States
Registrant address
10 ANG MO KIO STREET 65, #01-01, TECHPOINT, Singapore 569059
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.