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510(k) Data Aggregation
K Number
K020041Device Name
IALUSET HYDROCOLLOID
Manufacturer
Date Cleared
2002-03-14
(66 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
INSTITUT BIOCHIMIQUE SA (IBSA)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For over-the-counter use, IALUSET HYDROCOLLOID may be applied to:
- abrasions
- lacerations
- minor cuts
- minor scalds
- minor burns
Under the supervision of a physician, IALUSET HYDROCOLLOID may also be applied to:
- leg ulcers (venous stasis ulcers, arterial ulcers)
- diabetic ulcers
- pressure ulcers (stage I IV)
- surgical wounds (postoperative, dermatological excisions, donor sites)
- burns (first and second degree only)
- traumatic wounds
Device Description
IALUSET HYDROCOLLOID is a 10 cm x 10 cm wound dressing comprised of an inner layer of hydrocolloids (containing sodium hyaluronate and sodium chondroitin sulfate) which are incorporated into an adhesive matrix and spread between a polyurethane film and a silicone release liner. The dressing absorbs wound exudate, thereby allowing for a moist environment that is conducive to normal wound healing. It does not adhere to the wound, which minimizes both pain and damage to the underlying tissue when the dressing is removed.
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